All BioSpace - All News BioSpace - Business BioSpace - Drug Development BioSpace - FDA BioSpace - Deals BioSpace - Policy BioSpace - Drug Delivery FiercePharma - Main FiercePharma - Manufacturing FiercePharma - Marketing FiercePharma - Vaccines BioPharma Dive FierceBiotech - Main FierceBiotech - Biotech FierceBiotech - Medtech FierceBiotech - CRO BioPharma Dive Kodiak skyrockets on positive study data for 2 eye drugs The Phase 3 findings suggested Kodiak might have multiple threats to Regeneron’s Eylea and added more than $3 billion to the company’s market value. September 28, 2026 BioPharma Dive An ‘off-the-shelf’ CAR-T therapy from Adicet shows promise against lupus Data from an early trial showed the company’s “gamma delta” cell therapy surpassed benchmarks set by personalized CAR-T treatments tested in lupus. September 28, 2026 BioSpace - All News Kodiak Sciences’ stock soars 166% after 2 assets match Eylea in Phase 3 trial Kodiak Sciences will head to regulators with one of the candidates, an anti-VEGF antibody called zenkuda, after the late-stage results. September 28, 2026 BioSpace - Business Kodiak Sciences’ stock soars 166% after 2 assets match Eylea in Phase 3 trial Kodiak Sciences will head to regulators with one of the candidates, an anti-VEGF antibody called zenkuda, after the late-stage results. September 28, 2026 BioSpace - Drug Development Kodiak Sciences’ stock soars 166% after 2 assets match Eylea in Phase 3 trial Kodiak Sciences will head to regulators with one of the candidates, an anti-VEGF antibody called zenkuda, after the late-stage results. September 28, 2026 BioSpace - All News FDA nod for Mirum’s Atebrioz makes 3 options for ultra-rare bone disease The approval of Mirum Pharmaceuticals’ ALK2 inhibitor for fibrodysplasia ossificans progressiva on Friday adds a third option for patients who had long been without any treatments, joining Regeneron’s recently approved... September 28, 2026 BioSpace - Drug Development FDA nod for Mirum’s Atebrioz makes 3 options for ultra-rare bone disease The approval of Mirum Pharmaceuticals’ ALK2 inhibitor for fibrodysplasia ossificans progressiva on Friday adds a third option for patients who had long been without any treatments, joining Regeneron’s recently approved... September 28, 2026 BioSpace - FDA FDA nod for Mirum’s Atebrioz makes 3 options for ultra-rare bone disease The approval of Mirum Pharmaceuticals’ ALK2 inhibitor for fibrodysplasia ossificans progressiva on Friday adds a third option for patients who had long been without any treatments, joining Regeneron’s recently approved... September 28, 2026 BioSpace - All News Merck inks up to $2.13B deal to dine with SciBrunch, gain rights to preclinical KRAS inhibitor Merck continues to diversify its cancer efforts as the clock ticks down on Keytruda’s patent, picking up rights to a preclinical oncology asset in a deal that could exceed $2... September 28, 2026 BioSpace - Business Merck inks up to $2.13B deal to dine with SciBrunch, gain rights to preclinical KRAS inhibitor Merck continues to diversify its cancer efforts as the clock ticks down on Keytruda’s patent, picking up rights to a preclinical oncology asset in a deal that could exceed $2... September 28, 2026 BioSpace - Drug Development Merck inks up to $2.13B deal to dine with SciBrunch, gain rights to preclinical KRAS inhibitor Merck continues to diversify its cancer efforts as the clock ticks down on Keytruda’s patent, picking up rights to a preclinical oncology asset in a deal that could exceed $2... September 28, 2026 BioSpace - Deals Merck inks up to $2.13B deal to dine with SciBrunch, gain rights to preclinical KRAS inhibitor Merck continues to diversify its cancer efforts as the clock ticks down on Keytruda’s patent, picking up rights to a preclinical oncology asset in a deal that could exceed $2... September 28, 2026 BioSpace - All News Report: What Powers Employee Engagement What drives meaningful employee engagement in today’s life sciences workplace? This BioSpace report explores the factors that shape how employees feel about their organizations and what employers can do to... September 28, 2026 BioPharma Dive Merck, Daiichi end plans to seek speedy approval of lung cancer ADC The FDA indicated that the data generated so far wouldn’t support an accelerated clearance of “I-DXd,” a setback that erases an edge Merck and Daiichi had over multiple fast-moving competitors. September 28, 2026 BioSpace - All News AbbVie wins FDA approval for Parkinson’s drug from $8.7B Cerevel takeover In the Phase 3 TEMPO program, AbbVie’s Juvmo elicited significant improvements in motor symptoms and prolonged periods with good symptom control. September 28, 2026 BioSpace - FDA AbbVie wins FDA approval for Parkinson’s drug from $8.7B Cerevel takeover In the Phase 3 TEMPO program, AbbVie’s Juvmo elicited significant improvements in motor symptoms and prolonged periods with good symptom control. September 28, 2026 BioSpace - All News Merck, Daiichi Sankyo retract accelerated approval request for lung cancer ADC Merck and Daiichi Sankyo’s withdrawal of an accelerated approval request for the antibody-drug conjugate ifinatamab deruxtecan is a “net positive” for rivals like GSK and Roche, according to RBC Capital... September 28, 2026 BioSpace - Drug Development Merck, Daiichi Sankyo retract accelerated approval request for lung cancer ADC Merck and Daiichi Sankyo’s withdrawal of an accelerated approval request for the antibody-drug conjugate ifinatamab deruxtecan is a “net positive” for rivals like GSK and Roche, according to RBC Capital... September 28, 2026 FierceBiotech - Main Roche drops muscle-sparing obesity antibody after flunked interim analysis Roche has slammed the brakes on an obesity antibody after the candidate showed little hope of hitting its endpoints in a phase 2 study. September 28, 2026 FierceBiotech - Biotech Roche drops muscle-sparing obesity antibody after flunked interim analysis Roche has slammed the brakes on an obesity antibody after the candidate showed little hope of hitting its endpoints in a phase 2 study. September 28, 2026 FierceBiotech - Main Mirum posts phase 3 hepatitis win for ‘commercially differentiated’ challenger to Gilead, Vir A phase 3 trial of Mirum Pharmaceuticals’ chronic hepatitis delta virus drug candidate has hit its primary endpoint, furthering the biotech’s efforts to enter a space recently colonized by Gilead... September 28, 2026 FierceBiotech - Biotech Mirum posts phase 3 hepatitis win for ‘commercially differentiated’ challenger to Gilead, Vir A phase 3 trial of Mirum Pharmaceuticals’ chronic hepatitis delta virus drug candidate has hit its primary endpoint, furthering the biotech’s efforts to enter a space recently colonized by Gilead... September 28, 2026 FierceBiotech - Main Scynexis bags $214M BARDA contract for antifungal development The Biomedical Advanced Research and Development Authority (BARDA) has awarded Scynexis a $214 million contract for the development of a treatment for invasive fungal infections. September 28, 2026 FierceBiotech - Biotech Scynexis bags $214M BARDA contract for antifungal development The Biomedical Advanced Research and Development Authority (BARDA) has awarded Scynexis a $214 million contract for the development of a treatment for invasive fungal infections. September 28, 2026 BioPharma Dive Kids shouldn’t have to organize childhood around medicine Fewer shots, no hour-long pharmacy runs: two families show what medicine built for real life means. September 28, 2026 BioPharma Dive Breakthrough therapies still need builders The next biopharma advantage will come from the talent and systems that turn discovery into scale. September 28, 2026 FierceBiotech - Main Tolerance continues thymus-focused deals with $560M pact for Tanabe's clinical-stage IL-33 drug After vaulting into the clinic by licensing a fusion protein last month, Tolerance Bio has continued to strengthen its thymus-focused pipeline by picking up an anti-IL-33 drug from Tanabe Pharma. September 28, 2026 FierceBiotech - Biotech Tolerance continues thymus-focused deals with $560M pact for Tanabe's clinical-stage IL-33 drug After vaulting into the clinic by licensing a fusion protein last month, Tolerance Bio has continued to strengthen its thymus-focused pipeline by picking up an anti-IL-33 drug from Tanabe Pharma. September 28, 2026 FierceBiotech - Main Precision Neuroscience taps $250M in Series D funding for brain-computer interface Precision Neurosciences, which specializes in brain-computer interface technology, raised $250 million in an oversubscribed Series D financing round. September 28, 2026 FierceBiotech - Medtech Precision Neuroscience taps $250M in Series D funding for brain-computer interface Precision Neurosciences, which specializes in brain-computer interface technology, raised $250 million in an oversubscribed Series D financing round. September 28, 2026 FierceBiotech - Main Kodiak's stock doubles as resurrected eye disease drug matches Eylea in phase 3 Two of Kodiak Sciences’ drug candidates have matched aflibercept in a phase 3 clinical trial, positioning the biotech to seek FDA approval of one of the eye disease assets this... September 28, 2026 FierceBiotech - Biotech Kodiak's stock doubles as resurrected eye disease drug matches Eylea in phase 3 Two of Kodiak Sciences’ drug candidates have matched aflibercept in a phase 3 clinical trial, positioning the biotech to seek FDA approval of one of the eye disease assets this... September 28, 2026 FierceBiotech - Main Merck pens $2.1B deal with China’s SciBrunch to chase KRAS G12D Merck & Co. has become the latest pharma to jump on the KRAS G12D bandwagon, paying $400 million to China’s SciBrunch for a preclinical candidate. September 28, 2026 FierceBiotech - Biotech Merck pens $2.1B deal with China’s SciBrunch to chase KRAS G12D Merck & Co. has become the latest pharma to jump on the KRAS G12D bandwagon, paying $400 million to China’s SciBrunch for a preclinical candidate. September 28, 2026 FierceBiotech - Main VC Sofinnova reels in €82M to target medtechs in the next 5 years Sofinnova Partners has hauled in 82 million euro ($93.3 million) in an oversubscribed financing round. The European venture capital group said it will use the cash to expand its medtech... September 28, 2026 FierceBiotech - Medtech VC Sofinnova reels in €82M to target medtechs in the next 5 years Sofinnova Partners has hauled in 82 million euro ($93.3 million) in an oversubscribed financing round. The European venture capital group said it will use the cash to expand its medtech... September 28, 2026 BioSpace - All News Regenerative medicine needs more than stem cells Stem cell therapies vary widely yet many physicians still treat them as interchangeable. A more credible model requires diagnostics, product characterization and conventional medical context to determine who and when... September 28, 2026 BioSpace - Drug Development Regenerative medicine needs more than stem cells Stem cell therapies vary widely yet many physicians still treat them as interchangeable. A more credible model requires diagnostics, product characterization and conventional medical context to determine who and when... September 28, 2026 BioSpace - Drug Delivery Regenerative medicine needs more than stem cells Stem cell therapies vary widely yet many physicians still treat them as interchangeable. A more credible model requires diagnostics, product characterization and conventional medical context to determine who and when... September 28, 2026 BioSpace - All News Milestone Sanfilippo nod helps Ultragenyx regroup after tough Angelman defeat The recent FDA approval of Fayuvi for a rare, childhood neurodegenerative disease was “particularly special” for Ultragenyx CEO Emil Kakkis. It could also, along with an August nod for another... September 28, 2026 BioSpace - Business Milestone Sanfilippo nod helps Ultragenyx regroup after tough Angelman defeat The recent FDA approval of Fayuvi for a rare, childhood neurodegenerative disease was “particularly special” for Ultragenyx CEO Emil Kakkis. It could also, along with an August nod for another... September 28, 2026 BioSpace - Drug Development Milestone Sanfilippo nod helps Ultragenyx regroup after tough Angelman defeat The recent FDA approval of Fayuvi for a rare, childhood neurodegenerative disease was “particularly special” for Ultragenyx CEO Emil Kakkis. It could also, along with an August nod for another... September 28, 2026 BioSpace - All News 6 immunology targets to sustain a mammoth I&I market Johnson & Johnson, Pfizer, Argenx and more are unlocking new immunology targets and looking to improve on existing ones in an attempt to catch some of the magic brought about... September 28, 2026 BioSpace - Business 6 immunology targets to sustain a mammoth I&I market Johnson & Johnson, Pfizer, Argenx and more are unlocking new immunology targets and looking to improve on existing ones in an attempt to catch some of the magic brought about... September 28, 2026 BioSpace - Drug Development 6 immunology targets to sustain a mammoth I&I market Johnson & Johnson, Pfizer, Argenx and more are unlocking new immunology targets and looking to improve on existing ones in an attempt to catch some of the magic brought about... September 28, 2026 FierceBiotech - Main Merck, Daiichi pull lung cancer filing after FDA pushback deals another blow to $4B deal Daiichi Sankyo and Merck & Co. have withdrawn an antibody-drug conjugate (ADC) filing after the FDA said they lacked the data for accelerated approval in a lung cancer population. September 28, 2026 FierceBiotech - Biotech Merck, Daiichi pull lung cancer filing after FDA pushback deals another blow to $4B deal Daiichi Sankyo and Merck & Co. have withdrawn an antibody-drug conjugate (ADC) filing after the FDA said they lacked the data for accelerated approval in a lung cancer population. September 28, 2026 BioPharma Dive This week in charts: Novo’s rise and fall and AI biotechs’ big haul The latest installment in BioPharma Dive’s data visualization series features a closer look at Novo's stock performance and the recent run of fundraising success for AI drug discovery startups. September 25, 2026 BioSpace - All News After COVID, biomanufacturing tackles preparedness and commercialization challenges Manufacturers are redesigning their processes to balance both better future emergency vaccine mobilization and the more demanding work of maintaining flexible, commercially viable manufacturing networks. September 25, 2026 BioSpace - Business After COVID, biomanufacturing tackles preparedness and commercialization challenges Manufacturers are redesigning their processes to balance both better future emergency vaccine mobilization and the more demanding work of maintaining flexible, commercially viable manufacturing networks. September 25, 2026 BioSpace - Drug Development After COVID, biomanufacturing tackles preparedness and commercialization challenges Manufacturers are redesigning their processes to balance both better future emergency vaccine mobilization and the more demanding work of maintaining flexible, commercially viable manufacturing networks. September 25, 2026 BioSpace - All News Nektar prevails in legal battle with Lilly over broken rezpeg partnership Nektar Therapeutics has been awarded $90 million in damages after a jury sided with the biotech, which had accused Big Pharma Eli Lilly of “botching” an analysis of their formerly... September 25, 2026 BioSpace - Business Nektar prevails in legal battle with Lilly over broken rezpeg partnership Nektar Therapeutics has been awarded $90 million in damages after a jury sided with the biotech, which had accused Big Pharma Eli Lilly of “botching” an analysis of their formerly... September 25, 2026 FierceBiotech - Main Adicet Bio CAR-T sparks lupus remissions in early trial as ‘new era’ of autoimmune treatment approaches As the race to harness CAR-T cells for autoimmune diseases hits a rough patch, a Bay Area biotech is gliding over the potholes with an early sign of efficacy in... September 25, 2026 FierceBiotech - Biotech Adicet Bio CAR-T sparks lupus remissions in early trial as ‘new era’ of autoimmune treatment approaches As the race to harness CAR-T cells for autoimmune diseases hits a rough patch, a Bay Area biotech is gliding over the potholes with an early sign of efficacy in... September 25, 2026 BioSpace - All News ADARx raises $446M in biotech’s third largest IPO of 2026, City files to go public Two RNA biotechs, ADARx Pharmaceuticals and City Therapeutics, are taking advantage of the IPO frenzy, which has led to a total of 27 newly public biotechs so far this year. September 25, 2026 BioSpace - Business ADARx raises $446M in biotech’s third largest IPO of 2026, City files to go public Two RNA biotechs, ADARx Pharmaceuticals and City Therapeutics, are taking advantage of the IPO frenzy, which has led to a total of 27 newly public biotechs so far this year. September 25, 2026 BioSpace - Drug Development ADARx raises $446M in biotech’s third largest IPO of 2026, City files to go public Two RNA biotechs, ADARx Pharmaceuticals and City Therapeutics, are taking advantage of the IPO frenzy, which has led to a total of 27 newly public biotechs so far this year. September 25, 2026 BioSpace - Deals ADARx raises $446M in biotech’s third largest IPO of 2026, City files to go public Two RNA biotechs, ADARx Pharmaceuticals and City Therapeutics, are taking advantage of the IPO frenzy, which has led to a total of 27 newly public biotechs so far this year. September 25, 2026 BioSpace - All News J&J, Legend tout long-term survival benefits for Carvykti in multiple myeloma Ten patients out of 20 who received Johnson & Johnson and Legend Biotech’s Carvykti remained alive at five years of follow up. September 25, 2026 BioSpace - Drug Development J&J, Legend tout long-term survival benefits for Carvykti in multiple myeloma Ten patients out of 20 who received Johnson & Johnson and Legend Biotech’s Carvykti remained alive at five years of follow up. September 25, 2026 BioPharma Dive Novo pursues long-acting obesity drugs; Acadia slumps on Alzheimer’s data Novo’s latest alliance involves injectables given every one to three months. Elsewhere, Nektar won a legal spat with Eli Lilly and the FDA issued two approvals. September 25, 2026 BioSpace - All News Genentech makes $1.5B+ deal with AI heavyweight Earendil for cancer bispecifics Genentech's agreement with Earendil Labs came the same day its parent company, Roche, inked a cardiometabolic and renal deal with Atavistik Bio for up to $2 billion. September 25, 2026 BioSpace - Business Genentech makes $1.5B+ deal with AI heavyweight Earendil for cancer bispecifics Genentech's agreement with Earendil Labs came the same day its parent company, Roche, inked a cardiometabolic and renal deal with Atavistik Bio for up to $2 billion. September 25, 2026 BioSpace - Deals Genentech makes $1.5B+ deal with AI heavyweight Earendil for cancer bispecifics Genentech's agreement with Earendil Labs came the same day its parent company, Roche, inked a cardiometabolic and renal deal with Atavistik Bio for up to $2 billion. September 25, 2026 FierceBiotech - Main Lundbeck to move US digs to Boston as it eyes bigger innovation frontiers With Lundbeck steering its R&D engine toward increasingly specialized neuroscience targets, the Danish drugmaker is plotting a U.S. HQ move to one of the country’s preeminent biopharma hotspots. September 25, 2026 FierceBiotech - Main Indivior ends PAM drug collab with Addex ahead of Supernus merger Ahead of its upcoming merger with Supernus, Indivior Pharmaceuticals has ended its long-running collaboration with Addex Therapeutics to develop positive allosteric modulators (PAMs). September 25, 2026 FierceBiotech - Biotech Indivior ends PAM drug collab with Addex ahead of Supernus merger Ahead of its upcoming merger with Supernus, Indivior Pharmaceuticals has ended its long-running collaboration with Addex Therapeutics to develop positive allosteric modulators (PAMs). September 25, 2026 FierceBiotech - Main Novo inks $1.3B Nanexa deal to unlock long-acting obesity injectables Novo has struck a 1.17 billion euro ($1.3 billion) deal to combine Nanexa’s long-acting injectable drug delivery platform with its obesity and Type 2 diabetes drugs. September 25, 2026 FierceBiotech - Biotech Novo inks $1.3B Nanexa deal to unlock long-acting obesity injectables Novo has struck a 1.17 billion euro ($1.3 billion) deal to combine Nanexa’s long-acting injectable drug delivery platform with its obesity and Type 2 diabetes drugs. September 25, 2026 FierceBiotech - Main Roche's Genentech inks $1.5B bispecific pact with fast-rising Earendil Roche’s Genentech is paying Earendil Labs $55 million upfront to discover and develop multiple bispecific antibodies. The deal, which focuses on oncology, includes milestones that could take the deal's value... September 25, 2026 FierceBiotech - Biotech Roche's Genentech inks $1.5B bispecific pact with fast-rising Earendil Roche’s Genentech is paying Earendil Labs $55 million upfront to discover and develop multiple bispecific antibodies. The deal, which focuses on oncology, includes milestones that could take the deal's value... September 25, 2026 FierceBiotech - Main ADARx scores upsized $446M IPO, while fellow RNA biotech City maps out Nasdaq plans ADARx Pharmaceuticals has overshot its own IPO ambitions, as fellow RNA-focused biotech City Therapeutics also plans a public listing. September 25, 2026 FierceBiotech - Biotech ADARx scores upsized $446M IPO, while fellow RNA biotech City maps out Nasdaq plans ADARx Pharmaceuticals has overshot its own IPO ambitions, as fellow RNA-focused biotech City Therapeutics also plans a public listing. September 25, 2026 BioPharma Dive RNAi drug specialist ADARx raises $446M IPO ADARx is the only maker of RNA-based drugs to go public since 2024 and the first RNAi biotech to price an IPO in the U.S. in more than a decade. September 25, 2026 FierceBiotech - Main Pioneer of China NewCo model sued in US over trade secret misuse, double-dealing A legal feud unfolding in New York is putting a spotlight on the work of a business development veteran who is credited for pioneering one of biopharma’s hottest dealmaking mechanism:... September 24, 2026 FierceBiotech - Biotech Pioneer of China NewCo model sued in US over trade secret misuse, double-dealing A legal feud unfolding in New York is putting a spotlight on the work of a business development veteran who is credited for pioneering one of biopharma’s hottest dealmaking mechanism:... September 24, 2026 BioPharma Dive Grail multicancer detection test wins FDA advisers’ backing Panel members said the first-of-a-kind blood test should not be used to replace medical guideline-recommended cancer screenings, however. September 24, 2026 BioPharma Dive FDA nominee Overton parries vaccine questions at Senate hearing Pressed by lawmakers on Thursday, Trump’s pick as the next FDA chief said she’d “follow the law” on key decisions and work to speed early drug research. September 24, 2026 BioSpace - All News FDA slams GLP-1 compounder over risk of contaminating drugs ‘with filth’ FDA inspectors found evidence that the compounding pharmacy was making versions of Eli Lilly’s tirzepatide and Novo’s semaglutide “regularly or in inordinate amounts” at a site with “insanitary conditions.” September 24, 2026 BioSpace - Business FDA slams GLP-1 compounder over risk of contaminating drugs ‘with filth’ FDA inspectors found evidence that the compounding pharmacy was making versions of Eli Lilly’s tirzepatide and Novo’s semaglutide “regularly or in inordinate amounts” at a site with “insanitary conditions.” September 24, 2026 BioSpace - FDA FDA slams GLP-1 compounder over risk of contaminating drugs ‘with filth’ FDA inspectors found evidence that the compounding pharmacy was making versions of Eli Lilly’s tirzepatide and Novo’s semaglutide “regularly or in inordinate amounts” at a site with “insanitary conditions.” September 24, 2026 BioSpace - Drug Delivery FDA slams GLP-1 compounder over risk of contaminating drugs ‘with filth’ FDA inspectors found evidence that the compounding pharmacy was making versions of Eli Lilly’s tirzepatide and Novo’s semaglutide “regularly or in inordinate amounts” at a site with “insanitary conditions.” September 24, 2026 BioSpace - All News US senators grill FDA nominee Overton on ability to ‘stand up’ to Trump In Thursday’s Senate committee meeting, FDA commissioner nominee Heidi Overton was repeatedly questioned about her ability to retain the FDA’s independence under President Donald Trump, as well as about her... September 24, 2026 BioSpace - FDA US senators grill FDA nominee Overton on ability to ‘stand up’ to Trump In Thursday’s Senate committee meeting, FDA commissioner nominee Heidi Overton was repeatedly questioned about her ability to retain the FDA’s independence under President Donald Trump, as well as about her... September 24, 2026 FierceBiotech - Main Chutes & Ladders—Travere chief makes way for former Amicus CEO Travere Therapeutics CEO Eric Dube, Ph.D., is stepping down after overseeing the launch of the rare kidney disease drug Filspari. September 24, 2026 FierceBiotech - Biotech Chutes & Ladders—Travere chief makes way for former Amicus CEO Travere Therapeutics CEO Eric Dube, Ph.D., is stepping down after overseeing the launch of the rare kidney disease drug Filspari. September 24, 2026 BioSpace - All News Acadia slides on Phase 2 miss in Alzheimer’s psychosis but keeps moving asset forward While Acadia Pharmaceuticals’ candidate has missed the main goal of a Phase 2 trial, the company is still moving forward with the anti-psychosis candidate in Alzheimer’s disease as well as... September 24, 2026 BioSpace - Business Acadia slides on Phase 2 miss in Alzheimer’s psychosis but keeps moving asset forward While Acadia Pharmaceuticals’ candidate has missed the main goal of a Phase 2 trial, the company is still moving forward with the anti-psychosis candidate in Alzheimer’s disease as well as... September 24, 2026 FierceBiotech - Main Trump's FDA pick Heidi Overton calls vaccines, mifepristone safe and effective in confirmation hearing The Senate Committee on Health, Education, Labor and Pensions (HELP) today questioned Heidi Overton, M.D., Ph.D., Trump’s pick for FDA commissioner, in a hearing marked by tightrope-walking on issues like... September 24, 2026 FierceBiotech - Biotech Trump's FDA pick Heidi Overton calls vaccines, mifepristone safe and effective in confirmation hearing The Senate Committee on Health, Education, Labor and Pensions (HELP) today questioned Heidi Overton, M.D., Ph.D., Trump’s pick for FDA commissioner, in a hearing marked by tightrope-walking on issues like... September 24, 2026 BioSpace - All News Merck’s experimental eye drug matches Roche’s VEGF inhibitor but safety concerns emerge Analysts were keen to see a new modality compete with Roche’s approved drug Lucentis in the late-stage trial but new safety issues could complicate the future for Merck’s candidate. September 24, 2026 BioSpace - All News Kyverna steps closer to FDA-first CAR T for an autoimmune condition with durability data Kyverna Therapeutics' miv-cel showed improved mobility and a favorable safety profile at one year in patients with stiff person syndrome, further derisking an upcoming FDA application, William Blair said on... September 24, 2026 BioSpace - All News Eli Lilly’s weekly insulin shot cleared by FDA, setting up another front in Novo rivalry The weekly insulin Onswik will now be available to U.S. patients after initial approvals in Europe, Mexico and Japan. September 24, 2026 BioSpace - FDA Eli Lilly’s weekly insulin shot cleared by FDA, setting up another front in Novo rivalry The weekly insulin Onswik will now be available to U.S. patients after initial approvals in Europe, Mexico and Japan. September 24, 2026 BioSpace - Deals Roche inks up to $2B deal with Atavistik for new cardiometabolic drugs The new partnership follows Roche’s recent R&D expansion in Boston focused on development for cardiovascular, renal and metabolic diseases. September 24, 2026 BioSpace - Deals Lilly sets aside up to $3.25B to tackle critical unmet need targets with InnoCare InnoCare Pharma is the latest addition to Eli Lilly’s dealmaking spree, which includes some of the biggest acquisitions this year: up to $7 billion for Kelonia Therapeutics in April and... September 24, 2026 BioSpace - Drug Delivery How radioligand therapy is rewriting cancer care In this episode of Denatured presented by Curium, Jennifer Smith-Parker speaks to Mike Patterson, CEO North America and Professor Sabine Brookman-May, vice president and head of Global Clinical Development. We... September 24, 2026 FierceBiotech - Main China’s Henlius carves out $440M T-cell engager deal with Amberstone Fosun Pharma subsidiary Henlius Biotech has signed a $440 million biobucks deal with California-based Amberstone Biosciences to work on T-cell engagers. September 24, 2026 FierceBiotech - Biotech China’s Henlius carves out $440M T-cell engager deal with Amberstone Fosun Pharma subsidiary Henlius Biotech has signed a $440 million biobucks deal with California-based Amberstone Biosciences to work on T-cell engagers. September 24, 2026 FierceBiotech - Main Acadia misses mark in Alzheimer’s but concludes phase 3 ‘absolutely worth’ pursuing Acadia Pharmaceuticals’ phase 2 Alzheimer’s disease trial has missed its primary endpoint, but the company and analysts alike saw enough encouraging signals to support the continuation of a phase 3 program. September 24, 2026 FierceBiotech - Biotech Acadia misses mark in Alzheimer’s but concludes phase 3 ‘absolutely worth’ pursuing Acadia Pharmaceuticals’ phase 2 Alzheimer’s disease trial has missed its primary endpoint, but the company and analysts alike saw enough encouraging signals to support the continuation of a phase 3 program. September 24, 2026 FierceBiotech - Biotech Merck sees pivotal victory for $3B eye disease prospect Merck & Co.’s Brunello trial has hit its primary endpoint, shedding light on the effects of a trispecific diabetic macular edema (DME) drug candidate that the Big Pharma bought in... September 24, 2026 FierceBiotech - Biotech Roche pens backloaded $2B deal with Atavistik to discover allosteric CVRM drugs Roche has penned a backloaded $2 billion deal with hematology biotech Atavistik Bio to develop allosteric small molecules for cardiometabolic diseases. September 24, 2026 FierceBiotech - Medtech Adagio Medical kicks off strategic review, trims more than half its staff Adagio Medical has initiated a strategic review of its business and will lay off more than half its full-time workers as the maker of cryoablation devices faces delisting on the... September 24, 2026 FierceBiotech - Biotech Lilly puts up $100M, plus billions on the backend, to form 5-target deal with China's InnoCare Eli Lilly has committed $100 million in upfront and near-term payments to InnoCare Pharma to form a five-target drug discovery pact. The deal features up to $3.25 billion in milestones. September 24, 2026 FierceBiotech - Medtech Grail survives adcomm vote as it awaits FDA decision for cancer blood test Despite a major trial setback earlier this year and increasing questions over its efficacy, medtech Grail has beaten the odds and seen a positive recommendation for its multi-cancer blood test... September 24, 2026 BioSpace - Deals AI drug hunter Enveda raises $311M for late-stage obesity, inflammatory disease push Tech darling Enveda has raised a total of $845 million in the past six years. The latest funding round is intended to pave the way for an IPO someday. September 23, 2026 BioSpace - Deals Amgen asset from $27.8B Horizon buy scores in Phase 3 Sjögren's study Amgen is awaiting another Phase 3 readout for the investigational Sjögren's disease therapy, set for later this year. William Blair anticipates that at least two trials will be needed to... September 23, 2026 BioSpace - Deals Novartis bets up to $900M for radioligand therapy from China’s BoomRay Novartis is the current radiopharma leader with two FDA-approved therapies in Pluvicto and Lutathera. September 23, 2026 BioSpace - Deals 2026 IPO stock tracker: How newly public biotechs are performing BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026. September 23, 2026 BioSpace - FDA Novo’s turnaround plan, weight loss wins, Ultragenyx’s Sanfilippo approval, IPO blitz Novo plans to hit $23B in revenue by 2035, has further reduced its workforce by 4,000 and is boosting manufacturing capacity for its Wegovy pill, but investors are unconvinced it... September 23, 2026 BioSpace - Policy China’s surging biotech sector represents both competition and lifeline for the US As Chinese companies push beyond “me-too” drugs and the country lays out a new five-year plan targeting a $522 billion–strong biotech industry by 2030, experts say more predictable funding and... September 23, 2026 BioSpace - FDA Compass vows to press on with FDA application despite new trial request Citing the urgent unmet need for patients with advanced biliary tract cancer, Compass Therapeutics will continue to seek an approval path for its drug after the FDA recommended the biotech... September 22, 2026 BioSpace - Drug Delivery Novo targets 10-fold jump in oral Wegovy manufacturing capacity by 2030 With sales of the oral GLP-1 medicine rising quickly, executives reassured investors that Novo has secured production capacity to support continued growth. September 22, 2026 BioSpace - Deals Boehringer Ingelheim bets up to $1B in AI-centered solid tumor collab with Envisagenics Envisagenics’ platform makes use of AI to screen and detect cancer-specific RNA alterations, which Boehringer Ingelheim wants to target through various precision treatment modalities, including multi-specific antibodies, antibody-drug conjugates and... September 22, 2026 FierceBiotech - Medtech Siemens Healthineers and Novo team up on fatty liver disease awareness, testing Siemens Healthineers is joining forces with Novo to help boost awareness and diagnosis of fatty liver disease. September 22, 2026 FierceBiotech - Medtech Cordis’ sirolimus drug-coated balloon earns FDA approval as a breakthrough device The FDA gave the green light to a first and only sirolimus drug-eluting balloon designed by Cordis to treat coronary in-stent restenosis. September 22, 2026 FierceBiotech - Medtech Anaconda Biomed snares $56M in funding for endovascular tech Medtech startup Anaconda Biomed has hauled in $53 million to help finish off work on a pivotal trial for its endovascular project. September 22, 2026 BioSpace - Drug Delivery Western licensing deals for Chinese radioligand therapies to jump in 2027, Sleuth forecasts Deals for Chinese radiopharmaceutical assets have been rare to date and there is a limited pool of potential Western buyers available, Sleuth said. September 21, 2026 BioSpace - FDA Mikhail, Davis on board with regulatory framework tailored to rare disease therapies Newly permanent CBER and CDER directors Karim Mikhail and Michael Davis are widely expected to continue the FDA’s efforts toward an adaptive framework for rare disease therapies. If approved by... September 21, 2026 BioSpace - FDA Ultragenyx wins FDA greenlight for first Sanfilippo therapy, priced at nearly $4M The market approval for Fayuvi, which was rejected in 2025 due to manufacturing problems, comes shortly after Ultragenyx got the FDA nod for its first gene therapy last month. September 18, 2026 FierceBiotech - Medtech Medtronic earns FDA clearance for LigaSure use with its Hugo robotic system The FDA has cleared Medtronic’s LigaSure RAS Maryland jaw vessel sealer-divider to be used in combination with the device maker’s Hugo robotic-assisted surgery system. September 18, 2026 FierceBiotech - Medtech FDA clears Aptitude’s latest Metrix molecular dx to test for COVID The FDA granted Aptitude its first 510(k) clearance for the next-generation Metrix COVID diagnostic that features three-times greater sensitivity with 30% faster results that its original emergency use authorized test. September 18, 2026 FierceBiotech - CRO DPHARM: How to address the clinical trial enrollment crisis? Clinical trials are facing an enrollment crisis. Around 80% of trials don’t meet their enrollment timelines, and fewer than 5% of eligible adult cancer patients participate in trials. September 17, 2026 BioSpace - FDA FDA warning letter accuses Bausch & Lomb of lacking commitment to remediation After reviewing Bausch & Lomb’s response to its observations, the FDA questioned whether the company is committed to implementing significant design remediations. September 16, 2026 BioSpace - Drug Delivery FDA warning letter accuses Bausch & Lomb of lacking commitment to remediation After reviewing Bausch & Lomb’s response to its observations, the FDA questioned whether the company is committed to implementing significant design remediations. September 16, 2026 FierceBiotech - Medtech Mayo Clinic teams with Thermo Fisher to form biomedical data group Precure The Mayo Clinic has partnered with Thermo Fisher Scientific to launch a new group focused on reaping large-scale data that could lead to the understanding and development of new treatments,... September 15, 2026 FierceBiotech - Medtech Newly formed Jaguar acquires Afib device assets from J&J Jaguar LAA, a newly formed medtech, has acquired assets that are part of Johnson & Johnson’s AFib device Laminar program for an undisclosed price. September 15, 2026 FierceBiotech - Medtech After rejection, FDA approves Telix’s Pixclara, the first FET-PET imaging drug for brain cancer The FDA has signed off on the first-ever glioma drug imaging diagnostic more than a year after it initially rejected the med. September 15, 2026 BioSpace - Drug Delivery Blood centers can help biopharma scale cell and gene therapies Blood centers have the donors, resources and community footprint drug sponsors need to solve supply chain issues around cell and gene therapies. September 15, 2026 BioSpace - Drug Delivery AAM sounds alarm on ‘unsustainable, race to the bottom’ for generics and biosimilars After years of price pressures, the trade group argues “the economics of generics have deteriorated to the point where sustainability of the industry is in peril.” September 14, 2026 BioSpace - Drug Delivery Cyclic peptides open new drug frontiers, if manufacturing can keep up With oral cyclic peptides offering small molecule convenience and antibody‑like selectivity, the modality is gaining momentum. But bioavailability below 1%, minimal PK data and fragile synthesis still slow progress. Viva... September 14, 2026 FierceBiotech - Medtech J&J looking to offload orthopedics unit in $20B deal to Apollo: Bloomberg Johnson & Johnson is nearing a $20 billion deal to sell off its unwanted hips-and-knees business, DePuy Synthes, to private equity firm Apollo Equity Management. September 13, 2026 FierceBiotech - Medtech GE HealthCare mulls $1B imaging chemicals maker deal: Financial Times GE HealthCare is said to be on the cusp of buying out radiopharmaceutical developer Sofie Biosciences, according to a report by the Financial Times. September 13, 2026 FierceBiotech - CRO Owkin, Servier ink oncology R&D deal to guide discovery and trial design AI drug discovery company Owkin has signed a pact with French drugmaker Servier to license Owkin’s AI scientist K Pro across Servier’s oncology discovery and trial operations. September 11, 2026 BioSpace - Drug Delivery Samsung Biologics inks $262M manufacturing deal with European pharma company The agreement, which runs through 2033, comes as Samsung Biologics continues to expand its large manufacturing footprint in South Korea. September 11, 2026 FierceBiotech - CRO nPhase launches AI clinical data management platform to soup up sponsor trial design Clinical research company nPhase has launched an end-to-end clinical data management platform designed to help trial sponsors leverage trial results with AI. September 9, 2026 FierceBiotech - Medtech Abbott garners FDA nod for its TactiFlex catheter to treat AFib Abbot received FDA clearance for its latest-generation catheter that allows physicians more flexibility when treating atrial fibrillation in patients. September 9, 2026 FierceBiotech - Medtech Labcorp snaps up MLM Medical Labs to boost laboratory footprint Medtech and testing giant Labcorp has bought out MLM Medical Labs to help grow its geographic footprint for laboratory services. September 9, 2026 FierceBiotech - Medtech Boston Scientific recalls spinal cord implant in wake of more than 1k serious injuries Boston Scientific has issued another recall, this time for its spinal cord implant used to treat pain. September 8, 2026 FierceBiotech - Medtech Boston Scientific cyberattack likely to have ‘material impact’ on financial results The recent cyberattack on Boston Scientific is looking more serious than the medtech major first thought, with the company predicting a possible hit to its third-quarter and full-year results. September 7, 2026 FierceBiotech - Medtech Guardant wins FDA nod for diagnostic guiding use of AstraZeneca’s Etcamah Hot on the heels of the approval of AstraZeneca’s breast cancer drug Etcamah, Guardant Health has been given the green light for its companion diagnostic. September 7, 2026 BioSpace - Policy FDA raises bar for foreign site inspections as China trials surge Inspection access is not “an administrative footnote,” leaders of key FDA divisions wrote in an editorial on Wednesday vowing to expand oversight of foreign clinical trial sites. September 2, 2026 FierceBiotech - CRO Fortrea boosts early-phase CRO platform with $45M acquisition of Worldwide division Fortrea has agreed to acquire the early-phase services division of fellow CRO Worldwide Clinical Trials for $45 million. September 2, 2026 BioSpace - Policy Tavneos no longer available for new patients in UK as Amgen awaits FDA hearing CSL Vifor holds the marketing authorization for Tavneos in the U.K., where the drug is marketed as Avacopan Vifor. It continues to be sold on the U.S. market by Amgen... September 2, 2026 BioSpace - Policy 9 midsize drugmakers climb aboard Trump’s MFN train Astellas Pharma, BridgeBio, BeOne Medicines and six other large biotechs join the 17 Big Pharmas that previously signed on to President Donald Trump’s Most Favored Nation (MFN) drug pricing program,... September 1, 2026 FierceBiotech - Medtech Novocure hit by cyberattack exposing patient data Novocure has become the latest medtech company to be hit by a cyberattack, with the oncology specialist revealing that unauthorized access to some of its information systems exposed patient and... September 1, 2026 BioSpace - Policy China poses increasing security risk as US biotech innovation edge erodes The U.S. is scrambling to compete with a strategically positioned China on the biotech stage as the Asian country surpasses America in biomedical research and clinical trials. So far, China... August 31, 2026 BioSpace - Policy Kennedy questions vaccination guidelines following Trump’s order to break up MMR The current classifications of vaccine recommendations could imply that not all shots require the consent of patients or their parents, according to Health Secretary Robert F. Kennedy Jr. August 24, 2026 BioSpace - Policy Lawmakers urge FDA to enact new China policies after 3 gene therapy trial deaths Three fatalities occurring recently in Chinese clinical trials have spurred two members of U.S. Congress to urge the FDA to enact new policies designed to protect American patients. August 21, 2026 FierceBiotech - CRO Medigen links up with Charles River in push to take enterovirus vaccine global Charles River Laboratories and Taiwan-based Medigen Vaccine Biologics are teaming up to advance Medigen’s multivalent enterovirus vaccine. August 20, 2026 BioSpace - Policy Trump's FDA pick Overton good for psychedelics, new pain meds but bad for vaccines: Analysts If confirmed by the Senate, Heidi Overton—officially revealed Wednesday as President Donald Trump’s choice for FDA commissioner—is expected to be a boon for developers of psychedelic therapeutics and non-opioid pain... August 19, 2026 FierceBiotech - CRO Merck and Sarah Cannon team up to boost oncology trial efficiency Oncology R&D organization Sarah Cannon Research Institute (SCRI) announced a collaboration with Merck & Co. to increase patient access to oncology trials at community-based sites in the U.S. August 19, 2026 FierceBiotech - CRO AI clinical monitoring agent can deliver up to 82 times the ROI in oncology: report A new analysis from the Tufts Center for the Study of Drug Development (CSDD) found that an AI clinical monitoring agent can deliver an estimated 82-fold return on investment in... August 12, 2026 BioSpace - Policy Psychedelics on the cusp of market breakthrough as clinical, policy support grow While there are several FDA-approved psychiatric medicines on the market, many patients still struggle to achieve lasting symptom relief. Psychedelics could help fill this gap. August 10, 2026 FierceBiotech - CRO Icon inks Anthropic partnership to deploy Claude into clinical trials Contract research organization Icon announced a multi-year collaboration with Anthropic this week to bring Claude’s AI capabilities to clinical trials. August 4, 2026 FierceBiotech - CRO Acrosian debuts as AI-focused biometrics CRO The founders of contract research organization Quartesian have reunited to form Acrosian, a CRO designed to be purpose-built for the AI era. July 28, 2026 BioSpace - Policy US ‘eroding’ lead in rare diseases a matter of national security: Report A Congressional advisory panel recommends the U.S. government put supportive policies in place for rare disease drug development, such as a finalized platform designation from the FDA and the allowance... July 22, 2026 FierceBiotech - CRO House passes bill directing FDA to update animal testing rules The U.S. House of Representatives passed the FDA Modernization Act 3.0 this week, and lawmakers and animal welfare advocates are celebrating the bill as a step toward a new era... July 22, 2026 FierceBiotech - CRO Over half of clinical trial sites see recruitment hindered by inefficiencies: survey A total of 59% of clinical trial sites are seeing fewer eligible patients recruited due to inefficiencies with their recruitment process, according to a recent survey. July 13, 2026 FierceBiotech - CRO Caidya and Simbec-Orion unite in global CRO combo Contract research organizations (CROs) Caidya and Simbec-Orion have united to create a new platform aimed at helping drug development programs accelerate and scale. July 7, 2026 FierceBiotech - CRO Icon names Microsoft tech partner as Q1 results grow analyst confidence Irish CRO giant Icon this week made Microsoft its technology partner as the organization advances its plan to increase investment in AI over the next three years. Microsoft’s Copilot and... June 24, 2026 FierceBiotech - CRO How data-driven diagnostic lab services drive precise clinical trial enrollment Drug commercialization depends on reaching the right physicians at the right moment. June 10, 2026 FierceBiotech - CRO From executive assistant to chief executive: Charles River CEO Birgit Girshick on ‘the next big transition’ in the CRO industry When Charles River Laboratories CEO Birgit Girshick started her career as an executive assistant with the company in Germany in 1989, she didn’t know what was possible for her career... June 9, 2026 FierceBiotech - CRO ASCO, Ryght AI team up for breast cancer trial site selection The American Society of Clinical Oncology (ASCO) and Ryght AI are teaming up to identify research sites for an ASCO clinical trial evaluating starting doses of CDK4/6 inhibitors in patients... June 1, 2026 FierceBiotech - CRO Icon ends internal accounting investigation, finds it overstated revenue in prior years Irish CRO Icon has concluded its investigation into its accounting practices and restated its consolidated financials for 2023 and 2024. May 28, 2026 FierceBiotech - CRO Kordata Dynamics launches with neural-focused AI clinical trial model Kordata Dynamics is emerging from stealth with the aim to redefine clinical trial execution by processing neural data while taking advantage of the FDA’s recent push for real-time clinical trials. May 27, 2026 FierceBiotech - CRO Clinical trial flaws ‘being scaled, not solved’ by AI: report Clinical trial data company Phesi’s new analysis found that fewer than one in three trial protocols are connected to documented patient data and outcomes, highlighting the risk that flawed decision-making... May 18, 2026 FierceBiotech - CRO Signant Health buys Ametris to unite data streams in clinical trials Tech provider Signant Health announced the acquisition of Ametris to unite its electronic clinical outcome assessments with Ametris’ wearable-derived digital outcome measures. May 14, 2026 Load More
