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 BioSpace - All News Cellectis could cut 70% of workforce in shift to in vivo therapies Cellectis’ business transformation could cost around 160 global employees their jobs. The company has stopped enrollment in its two CAR T programs as it focuses on trials of its in... November 13, 2026 BioSpace - Business Cellectis could cut 70% of workforce in shift to in vivo therapies Cellectis’ business transformation could cost around 160 global employees their jobs. The company has stopped enrollment in its two CAR T programs as it focuses on trials of its in... November 13, 2026 BioSpace - All News PharmaLogic buys Lantheus plant to build transatlantic radiopharmaceutical CDMO Less than two years after acquiring the assets, Lantheus is selling its CDMO unit and a New Jersey production plant to PharmaLogic. November 13, 2026 BioSpace - Business PharmaLogic buys Lantheus plant to build transatlantic radiopharmaceutical CDMO Less than two years after acquiring the assets, Lantheus is selling its CDMO unit and a New Jersey production plant to PharmaLogic. November 13, 2026 BioSpace - Deals PharmaLogic buys Lantheus plant to build transatlantic radiopharmaceutical CDMO Less than two years after acquiring the assets, Lantheus is selling its CDMO unit and a New Jersey production plant to PharmaLogic. November 13, 2026 BioSpace - Drug Delivery PharmaLogic buys Lantheus plant to build transatlantic radiopharmaceutical CDMO Less than two years after acquiring the assets, Lantheus is selling its CDMO unit and a New Jersey production plant to PharmaLogic. November 13, 2026 BioSpace - All News Milestone cutting 20% of HQ team, including CMO Follow along as BioSpace tracks job cuts and restructuring initiatives. November 13, 2026 BioSpace - Business Milestone cutting 20% of HQ team, including CMO Follow along as BioSpace tracks job cuts and restructuring initiatives. November 13, 2026 BioSpace - All News Arrowhead’s Ionis problem, Kyverna’s next-gen end and more biotech earnings When Ionis Pharmaceuticals’ Tryngolza undersold, investors immediately looked to Arrowhead Pharmaceuticals’ executives for answers on how they will navigate a launch in the same market. November 13, 2026 BioSpace - Business Arrowhead’s Ionis problem, Kyverna’s next-gen end and more biotech earnings When Ionis Pharmaceuticals’ Tryngolza undersold, investors immediately looked to Arrowhead Pharmaceuticals’ executives for answers on how they will navigate a launch in the same market. November 13, 2026 BioSpace - All News HHS pumps up to $25M into ibogaine, other psychotropic drugs on Veteran’s Day Ibogaine, which operates via a “matrix pharmacology,” has long been a focus of Health Secretary Robert F. Kennedy Jr. and the Trump administration. November 13, 2026 BioSpace - Drug Development HHS pumps up to $25M into ibogaine, other psychotropic drugs on Veteran’s Day Ibogaine, which operates via a “matrix pharmacology,” has long been a focus of Health Secretary Robert F. Kennedy Jr. and the Trump administration. November 13, 2026 BioSpace - FDA HHS pumps up to $25M into ibogaine, other psychotropic drugs on Veteran’s Day Ibogaine, which operates via a “matrix pharmacology,” has long been a focus of Health Secretary Robert F. Kennedy Jr. and the Trump administration. November 13, 2026 BioSpace - All News Windward nets $175M IPO, bringing 2026 biotech debuts to 35 Windward Bio’s public debut brings this year’s IPO count well above the sluggish total of eight in 2025. November 13, 2026 BioSpace - Business Windward nets $175M IPO, bringing 2026 biotech debuts to 35 Windward Bio’s public debut brings this year’s IPO count well above the sluggish total of eight in 2025. November 13, 2026 BioSpace - Drug Development Windward nets $175M IPO, bringing 2026 biotech debuts to 35 Windward Bio’s public debut brings this year’s IPO count well above the sluggish total of eight in 2025. November 13, 2026 BioSpace - Deals Windward nets $175M IPO, bringing 2026 biotech debuts to 35 Windward Bio’s public debut brings this year’s IPO count well above the sluggish total of eight in 2025. November 13, 2026 BioPharma Dive Novo submits sickle cell drug; Flagship, Gates Foundation deepen ties Novo views the medicine, acquired in a billion-dollar deal, as a future blockbuster. Meanwhile, a pair of startups forged an RNA editing pact and Astellas lined up two new trials... November 13, 2026 BioPharma Dive This week in charts: Brain drugs are back on venture capitalists’ minds Five neurology-focused startups have together raised around $450 million in the last few weeks. Elsewhere, investors had a muted response to the latest cell therapy research. November 13, 2026 BioSpace - All News Regeneron’s POTS antibody curbs heart rate spikes, teeing up Phase 3 trial Regeneron’s mid-stage success in postural orthostatic tachycardia syndrome has the company gearing up to launch a Phase 3 study in the first half of 2027. November 13, 2026 BioSpace - Business Regeneron’s POTS antibody curbs heart rate spikes, teeing up Phase 3 trial Regeneron’s mid-stage success in postural orthostatic tachycardia syndrome has the company gearing up to launch a Phase 3 study in the first half of 2027. November 13, 2026 BioSpace - Drug Development Regeneron’s POTS antibody curbs heart rate spikes, teeing up Phase 3 trial Regeneron’s mid-stage success in postural orthostatic tachycardia syndrome has the company gearing up to launch a Phase 3 study in the first half of 2027. November 13, 2026 BioSpace - All News Biopharma pushes beyond GLP-1s, weight loss at ObesityWeek 2026 ObesityWeek 2026, which kicks off on Saturday, will spotlight presentations on the ascendant amylin pathway, as well as therapies looking to improve the quality of weight loss and patients’ persistence... November 13, 2026 BioSpace - Drug Development Biopharma pushes beyond GLP-1s, weight loss at ObesityWeek 2026 ObesityWeek 2026, which kicks off on Saturday, will spotlight presentations on the ascendant amylin pathway, as well as therapies looking to improve the quality of weight loss and patients’ persistence... November 13, 2026 FierceBiotech - Main The promise of molecular gates and what comes next Gate Bioscience is developing a new class of medicines designed to eliminate disease-causing proteins at their source. In this episode of "The Top Line," Gate co-founder and CEO Jordi Mata-Fink,... November 13, 2026 FierceBiotech - Biotech The promise of molecular gates and what comes next Gate Bioscience is developing a new class of medicines designed to eliminate disease-causing proteins at their source. In this episode of "The Top Line," Gate co-founder and CEO Jordi Mata-Fink,... November 13, 2026 FierceBiotech - Main Charles River pays $470M for 2 Frontage bioanalysis labs in Pennsylvania Charles River Laboratories has acquired Tigermed’s Frontage laboratory sites for $470 million upfront to advance its bioanalysis footprint. November 13, 2026 FierceBiotech - CRO Charles River pays $470M for 2 Frontage bioanalysis labs in Pennsylvania Charles River Laboratories has acquired Tigermed’s Frontage laboratory sites for $470 million upfront to advance its bioanalysis footprint. November 13, 2026 FierceBiotech - Main Rezolute gets an uplift from phase 3 tumor hyperinsulinism win ahead of FDA meeting A phase 3 clinical trial of Rezolute’s ersodetug in tumor hyperinsulinism has hit its primary endpoint, boosting the biotech ahead of a potential filing for FDA approval in another indication. November 13, 2026 FierceBiotech - Biotech Rezolute gets an uplift from phase 3 tumor hyperinsulinism win ahead of FDA meeting A phase 3 clinical trial of Rezolute’s ersodetug in tumor hyperinsulinism has hit its primary endpoint, boosting the biotech ahead of a potential filing for FDA approval in another indication. November 13, 2026 FierceBiotech - Main American Cancer Society updates prostate cancer screening guidance For the first time in 16 years, the American Cancer Society (ACS) has updated its guideline for prostate cancer screening as it drives to boost detection of the disease before... November 13, 2026 FierceBiotech - Medtech American Cancer Society updates prostate cancer screening guidance For the first time in 16 years, the American Cancer Society (ACS) has updated its guideline for prostate cancer screening as it drives to boost detection of the disease before... November 13, 2026 FierceBiotech - Main Virtuoso Surgical nabs FDA authorization for robotic bladder lesions system The FDA has granted De Novo authorization for Virtuoso Surgical’s Virtuoso Endoscopy System. November 13, 2026 FierceBiotech - Medtech Virtuoso Surgical nabs FDA authorization for robotic bladder lesions system The FDA has granted De Novo authorization for Virtuoso Surgical’s Virtuoso Endoscopy System. November 13, 2026 FierceBiotech - Main Sanofi-backed Windward hits $225M IPO goal, as Rezera delays listing over ‘market conditions’ Windward Bio’s IPO has blown to exactly the spot the Swiss biotech had been aiming for, bringing in $225 million to fund a pair of respiratory drugs licensed from China. November 13, 2026 FierceBiotech - Biotech Sanofi-backed Windward hits $225M IPO goal, as Rezera delays listing over ‘market conditions’ Windward Bio’s IPO has blown to exactly the spot the Swiss biotech had been aiming for, bringing in $225 million to fund a pair of respiratory drugs licensed from China. November 13, 2026 FierceBiotech - Main Cellectis will shed 70% of workforce as part of in vivo pivot Cellectis’ pivot from allogeneic CAR-Ts to in vivo therapies is set to come at the expense of 70% of its workforce. November 13, 2026 FierceBiotech - Biotech Cellectis will shed 70% of workforce as part of in vivo pivot Cellectis’ pivot from allogeneic CAR-Ts to in vivo therapies is set to come at the expense of 70% of its workforce. November 13, 2026 FierceBiotech - Main Regeneron posts positive phase 2 data for baloncibart in nervous system disorder, eyes pivotal trial Regeneron has posted positive phase 2 data on baloncibart in postural orthostatic tachycardia syndrome, teeing the biotech up to start a potentially pivotal trial in the first half of 2027. November 13, 2026 FierceBiotech - Biotech Regeneron posts positive phase 2 data for baloncibart in nervous system disorder, eyes pivotal trial Regeneron has posted positive phase 2 data on baloncibart in postural orthostatic tachycardia syndrome, teeing the biotech up to start a potentially pivotal trial in the first half of 2027. November 13, 2026 BioPharma Dive Windward prices $175M IPO to advance China-licensed lung drugs The Swiss biotech, which pocketed another $50 million through a concurrent private share sale to Sanofi, is developing a potential competitor to the blockbuster asthma treatment Tezspire. November 13, 2026 BioSpace - All News Webinar: Optimizing Cell Therapy Manufacturing Efficiency with Cryopreserved Cells In this webinar, we will show how delayed isolation and cryopreservation of immune cells from fresh leukopaks can drastically impact their stability and functionality. We will also explore how purified... November 12, 2026 BioSpace - All News Deep dive: Cardiovascular calamities and catalysts BioSpace reviews upcoming cardiovascular milestones after a summer of missed targets. November 12, 2026 BioSpace - Drug Development Deep dive: Cardiovascular calamities and catalysts BioSpace reviews upcoming cardiovascular milestones after a summer of missed targets. November 12, 2026 BioSpace - FDA Deep dive: Cardiovascular calamities and catalysts BioSpace reviews upcoming cardiovascular milestones after a summer of missed targets. November 12, 2026 BioPharma Dive Blackstone bets $1.5B on Pfizer’s obesity drug The deal will support a sprawling Phase 3 program for a monthly GLP-1 shot Pfizer acquired by winning a bidding war for the drug’s previous owner, Metsera. November 12, 2026 BioSpace - All News Neurosterix nabs $105M, recruits Karuna veterans for schizophrenia push Addex Therapeutics spinout Neurosterix will use the series B funds to advance an oral drug targeting M4, a muscarinic receptor also targeted by BMS’ Cobenfy, which introduced a new mechanism... November 12, 2026 BioSpace - Business Neurosterix nabs $105M, recruits Karuna veterans for schizophrenia push Addex Therapeutics spinout Neurosterix will use the series B funds to advance an oral drug targeting M4, a muscarinic receptor also targeted by BMS’ Cobenfy, which introduced a new mechanism... November 12, 2026 BioSpace - Drug Development Neurosterix nabs $105M, recruits Karuna veterans for schizophrenia push Addex Therapeutics spinout Neurosterix will use the series B funds to advance an oral drug targeting M4, a muscarinic receptor also targeted by BMS’ Cobenfy, which introduced a new mechanism... November 12, 2026 BioSpace - Deals Neurosterix nabs $105M, recruits Karuna veterans for schizophrenia push Addex Therapeutics spinout Neurosterix will use the series B funds to advance an oral drug targeting M4, a muscarinic receptor also targeted by BMS’ Cobenfy, which introduced a new mechanism... November 12, 2026 BioPharma Dive Bristol Myers research chief to depart in ‘evolution’ of company’s structure Robert Plenge is leaving as part of a shift that will see the company merge together its R&D department in a bid to speed development and capitalize on new technologies. November 12, 2026 BioSpace - All News FDA’s commissioner voucher program reportedly shuttered ahead of Senate vote on Overton In advance of a Senate vote on Heidi Overton as the next FDA commissioner, the agency has shelved the Commissioner's National Priority Voucher program introduced by former leader Marty Makary,... November 12, 2026 BioSpace - FDA FDA’s commissioner voucher program reportedly shuttered ahead of Senate vote on Overton In advance of a Senate vote on Heidi Overton as the next FDA commissioner, the agency has shelved the Commissioner's National Priority Voucher program introduced by former leader Marty Makary,... November 12, 2026 FierceBiotech - Main Chutes & Ladders—Bristol Myers' research chief out amid R&D reorganization Bristol Myers Squibb's research chief is departing as the company restructures R&D. Summit Therapeutics cut ties with multiple launch team members, including its CCO, ahead of a high-stakes FDA decision.... November 12, 2026 FierceBiotech - Biotech Chutes & Ladders—Bristol Myers' research chief out amid R&D reorganization Bristol Myers Squibb's research chief is departing as the company restructures R&D. Summit Therapeutics cut ties with multiple launch team members, including its CCO, ahead of a high-stakes FDA decision.... November 12, 2026 BioPharma Dive The FDA has over 1k open jobs — and the staffing shortage is hitting pharma The agency is still recovering from a mass staff exodus last year that left it shorthanded. Here’s what it means for the industry. November 12, 2026 BioSpace - All News Pfizer snags $1.5B financing from PE firm Blackstone to support Metsera asset With 10 active or planned Phase 3 trials underway for Metsera’s berobenatide, Pfizer has signed a deal with Blackstone Life Sciences to finance the program to approval. November 12, 2026 BioSpace - Business Pfizer snags $1.5B financing from PE firm Blackstone to support Metsera asset With 10 active or planned Phase 3 trials underway for Metsera’s berobenatide, Pfizer has signed a deal with Blackstone Life Sciences to finance the program to approval. November 12, 2026 BioSpace - Deals Pfizer snags $1.5B financing from PE firm Blackstone to support Metsera asset With 10 active or planned Phase 3 trials underway for Metsera’s berobenatide, Pfizer has signed a deal with Blackstone Life Sciences to finance the program to approval. November 12, 2026 BioSpace - All News BMS R&D head to depart amid restructure Bristol Myers Squibb is combining all research and development efforts under one leader as pressure rises to replenish its pipeline. November 12, 2026 BioSpace - Business BMS R&D head to depart amid restructure Bristol Myers Squibb is combining all research and development efforts under one leader as pressure rises to replenish its pipeline. November 12, 2026 BioSpace - Drug Development BMS R&D head to depart amid restructure Bristol Myers Squibb is combining all research and development efforts under one leader as pressure rises to replenish its pipeline. November 12, 2026 FierceBiotech - Main ARPA-H bets $4.9 million on ibogaine for PTSD treatment in veterans The U.S. department of health and human services announced a $4.9 million bet to advance the development of ibogaine for post-traumatic stress disorder (PTSD). November 12, 2026 FierceBiotech - Biotech ARPA-H bets $4.9 million on ibogaine for PTSD treatment in veterans The U.S. department of health and human services announced a $4.9 million bet to advance the development of ibogaine for post-traumatic stress disorder (PTSD). November 12, 2026 BioSpace - All News Can we finally get ahead of drug shortages? In this episode of Denatured, you'll hear from Christina Smolke, co-founder & CEO at Antheia and Kyle Pudenz, senior vice president and head of data & AI product at Cencora.... November 12, 2026 BioSpace - Drug Development Can we finally get ahead of drug shortages? In this episode of Denatured, you'll hear from Christina Smolke, co-founder & CEO at Antheia and Kyle Pudenz, senior vice president and head of data & AI product at Cencora.... November 12, 2026 BioSpace - Drug Delivery Can we finally get ahead of drug shortages? In this episode of Denatured, you'll hear from Christina Smolke, co-founder & CEO at Antheia and Kyle Pudenz, senior vice president and head of data & AI product at Cencora.... November 12, 2026 FierceBiotech - Main FDA appears to pause controversial speedy review program, complete response letter disclosures The FDA has quietly shelved the Commissioner’s National Priority Voucher (CNPV) pilot program, Reuters reports. Meanwhile, the agency also appears to have paused publishing complete response letters after briefly halting—and... November 12, 2026 FierceBiotech - Main Vor pays RemeGen $10M for long-acting addition to autoimmune pipeline Vor Bio is paying RemeGen $10 million upfront in cash for rights to RC298 outside Greater China, adding a long-acting drug candidate to its BAFF/APRIL franchise. November 12, 2026 FierceBiotech - Biotech Vor pays RemeGen $10M for long-acting addition to autoimmune pipeline Vor Bio is paying RemeGen $10 million upfront in cash for rights to RC298 outside Greater China, adding a long-acting drug candidate to its BAFF/APRIL franchise. November 12, 2026 FierceBiotech - Main Kyverna abandons next-gen autoimmune CAR-T once touted as follow-up to miv-cel Kyverna is halting work on a next-gen CD19 CAR-T therapy as the biotech seeks FDA approval for what could become the first CAR-T treatment for an autoimmune disease. November 12, 2026 FierceBiotech - Biotech Kyverna abandons next-gen autoimmune CAR-T once touted as follow-up to miv-cel Kyverna is halting work on a next-gen CD19 CAR-T therapy as the biotech seeks FDA approval for what could become the first CAR-T treatment for an autoimmune disease. November 12, 2026 FierceBiotech - Main BMS reunites R&D divisions under Cristian Massacesi, while Robert Plenge departs Bristol Myers Squibb is merging its research and development divisions under the leadership of Cristian Massacesi, M.D. November 12, 2026 FierceBiotech - Biotech BMS reunites R&D divisions under Cristian Massacesi, while Robert Plenge departs Bristol Myers Squibb is merging its research and development divisions under the leadership of Cristian Massacesi, M.D. November 12, 2026 BioSpace - All News 2026 Q3 Job Market Report: Job opportunities, layoffs show YOY improvement During Q3, there was a 31% year-over-year increase in job postings live on BioSpace. The number of employees affected by layoffs dropped 90%. November 12, 2026 BioSpace - All News Biopharma layoffs rise YOY in October but sharply trend down for 2026 October marked the first time this year there was an increase in both the number of biotech and pharma companies trimming their workforces and the number of affected employees when... November 12, 2026 BioSpace - Business Biopharma layoffs rise YOY in October but sharply trend down for 2026 October marked the first time this year there was an increase in both the number of biotech and pharma companies trimming their workforces and the number of affected employees when... November 12, 2026 BioSpace - All News 10 companies hiring in New Jersey Looking for a biopharma job in New Jersey? Jobs on BioSpace increased year over year in October, and there are hundreds of open positions posted now. November 12, 2026 FierceBiotech - Main Addex spinout Neurosterix raises $105M series B to fund phase 2 schizophrenia trial Addex Therapeutics’ neuropsychiatric-focused spinout has raised $105 million in series B funds to bankroll a planned phase 2 study of its schizophrenia treatment. November 12, 2026 FierceBiotech - Biotech Addex spinout Neurosterix raises $105M series B to fund phase 2 schizophrenia trial Addex Therapeutics’ neuropsychiatric-focused spinout has raised $105 million in series B funds to bankroll a planned phase 2 study of its schizophrenia treatment. November 12, 2026 FierceBiotech - Main Pfizer taps Blackstone for up to $1.5B to pave path to GLP-1's obesity launch Pfizer has secured up to $1.5 billion from Blackstone Life Sciences to fund development of its monthly GLP-1 receptor agonist. November 12, 2026 FierceBiotech - Biotech Pfizer taps Blackstone for up to $1.5B to pave path to GLP-1's obesity launch Pfizer has secured up to $1.5 billion from Blackstone Life Sciences to fund development of its monthly GLP-1 receptor agonist. November 12, 2026 FierceBiotech - Main Why a fresh approach to targeting G protein-coupled receptors could treat a rare eye cancer Researchers found that only by targeting both the G protein-coupled receptor and its mutated internal molecular switch can uveal melanoma cell signaling be disrupted. November 11, 2026 BioSpace - All News FDA warns Chinese providers of compounding APIs over record-request refusals Neither Chongqing Qiancan Technology nor Tianjin Healthcare Medical Technology provided the records requested by the FDA, leading the agency to issue import alerts and warning letters. November 11, 2026 BioSpace - FDA FDA warns Chinese providers of compounding APIs over record-request refusals Neither Chongqing Qiancan Technology nor Tianjin Healthcare Medical Technology provided the records requested by the FDA, leading the agency to issue import alerts and warning letters. November 11, 2026 BioSpace - Drug Delivery FDA warns Chinese providers of compounding APIs over record-request refusals Neither Chongqing Qiancan Technology nor Tianjin Healthcare Medical Technology provided the records requested by the FDA, leading the agency to issue import alerts and warning letters. November 11, 2026 BioPharma Dive Drug price hikes in Germany could push US costs higher, study says The report comes amid escalating tensions between the U.S. and Germany over drug prices, with several large pharmaceutical companies responding by scaling back investments in the country. November 11, 2026 BioSpace - All News PepGen shares almost double as DM1 oligonucleotide achieves ‘best in class’ splicing Mean splicing correction for PepGen’s PGN-EDODM1 was 46.5% at week 13, compared to under 30% for competitors like Dyne Therapeutics, Novartis and Ionis Pharmaceuticals. November 11, 2026 BioSpace - Drug Development PepGen shares almost double as DM1 oligonucleotide achieves ‘best in class’ splicing Mean splicing correction for PepGen’s PGN-EDODM1 was 46.5% at week 13, compared to under 30% for competitors like Dyne Therapeutics, Novartis and Ionis Pharmaceuticals. November 11, 2026 BioSpace - FDA Capricor parts ways with 10% of staff as FDA decision on DMD cell therapy nears Awaiting a decision on Nov. 22 for its embattled Duchenne muscular dystrophy cell therapy deramiocel, Capricor has reduced its workforce by 10% and slowed programs not directly related to deramiocel,... November 11, 2026 FierceBiotech - Main ‘They’ve been misdiagnosed for too long’: Researchers use 10-protein panel to improve ALS detection By the time a neurodegenerative condition has been diagnosed, it's often too late. At the point of detection, the disease may already be causing irreversible damage, fueling an urgent search... November 11, 2026 BioSpace - Drug Development Capricor ramps up manufacturing spend ahead of FDA decision for DMD therapy Less than two weeks away from a highly anticipated FDA ruling on its cell therapy for Duchenne muscular dystrophy, Capricor Therapeutics has reported increased investment in its San Diego plant... November 11, 2026 BioSpace - FDA Capricor ramps up manufacturing spend ahead of FDA decision for DMD therapy Less than two weeks away from a highly anticipated FDA ruling on its cell therapy for Duchenne muscular dystrophy, Capricor Therapeutics has reported increased investment in its San Diego plant... November 11, 2026 BioPharma Dive AstraZeneca buys vaccine startup; FDA issues GLP-1 safety warning The deal gives AstraZeneca a simpler way to make conjugate vaccines. Elsewhere, a psychedelic depression drug was submitted to the FDA and an autoimmune disease-focused biotech’s shares collapsed. November 11, 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. November 11, 2026 BioSpace - FDA Novartis’ Zolgensma woes, BIO’s China plan, GLP-1s’ new safety warning, FDA’s stacked November Novartis confirms that nine patients treated with its spinal muscular atrophy gene therapy Zolgensma have developed tumors; the FDA orders GLP-1 drugmakers to add a warning to their labels about... November 11, 2026 FierceBiotech - Main Valo and Montai become one as the Flagship AI-based biotechs tie the knot Two Flagship Pioneering-founded AI drug discovery and development biotechs, Valo Health and Montai Therapeutics, will join forces in a merger that aims to advance Montai’s early-stage and preclinical pipeline as... November 11, 2026 FierceBiotech - Biotech Valo and Montai become one as the Flagship AI-based biotechs tie the knot Two Flagship Pioneering-founded AI drug discovery and development biotechs, Valo Health and Montai Therapeutics, will join forces in a merger that aims to advance Montai’s early-stage and preclinical pipeline as... November 11, 2026 FierceBiotech - Main BioNTech pays $205M for FDA voucher to speed up ‘late-stage oncology pipeline’ BioNTech has agreed to pay $205 million to purchase an FDA priority review voucher to support a future filing of a drug in its “late-stage oncology pipeline.” Fierce breaks down... November 11, 2026 FierceBiotech - Biotech Capricor, NextCure shed light on recent layoffs as they gear up for approval decision, merger Capricor and NextCure have shed light on recent rounds of layoffs, as the biotechs brace for a hoped-for drug approval and merger, respectively. November 11, 2026 FierceBiotech - Biotech Amgen builds Sjögren’s case with detailed phase 3 data ahead of Novartis showdown Amgen has shared more data from a phase 3 Sjögren’s disease trial that dazzled analysts, digging into the details that could shape its showdown with Novartis. November 11, 2026 FierceBiotech - Medtech Abbott nabs FDA approval, CE Mark for implantable cardioverter-defibrillator lead Abbott has received both FDA and CE Mark approval for its UltiSynq defibrillation lead tech, which is designed to deliver both conduction system pacing and defibrillation therapy. November 11, 2026 BioPharma Dive PepGen soars on promising early data for muscular dystrophy drug While from a small study, the findings suggest PepGen’s therapy compares favorably to other RNA-based medicines in testing at Novartis and Dyne Therapeutics. November 10, 2026 BioSpace - FDA FDA's rare disease framework faces its first real test in Capricor’s DMD drug Last month, the FDA committed to designing a "fit-for-purpose" framework for regulating rare disease therapies based on patient need and realistically attainable evidence. With the upcoming decision for Capricor’s Duchenne... November 10, 2026 BioPharma Dive Beam’s base editing therapy for sickle cell hits goal in pivotal trial The result represents a scientific milestone and positions Beam to submit a first-of-its-kind FDA application as soon as the end of the year. November 10, 2026 BioSpace - FDA Bayer wins first-in-class FDA nod for blood thinner, setting stage for BMS-J&J rival Bayer’s Sunharbo has secured the first FDA approval of its class, establishing a regulatory pathway for other factor XIa inhibitors, such as Bristol Myers Squibb and Johnson and Johnson’s milvexian. November 10, 2026 FierceBiotech - Biotech Beam’s sickle cell therapy results tee up potential Casgevy, Lyfgenia showdown Gearing up for a potential FDA filing by the end of the year, Beam Therapeutics revealed results from a phase 1/2 study of its base-edited cell therapy risto-cel, showing the... November 10, 2026 BioSpace - FDA Altimmune gears up for FDA meeting on pivotal Phase 3 trial in alcohol use disorder Having linked its glucagon/GLP-1 candidate to a significant reduction in heavy drinking days, Altimmune is preparing to speak to the FDA in December about the design of a Phase 3... November 10, 2026 FierceBiotech - CRO Start Center for Cancer Research opens first early-phase clinical trial site in Italy Start Center for Cancer Research has expanded into Italy, partnering with Istituti Fisioterapici Ospitalieri to open its first early-phase cancer clinical trial site in the country. November 10, 2026 FierceBiotech - Biotech PepGen’s stock doubles as midphase muscle dystrophy data wow analysts PepGen’s phase 2 myotonic dystrophy type 1 data have met analysts’ best-case scenario, causing the biotech’s share price to more than double. November 10, 2026 FierceBiotech - Biotech AstraZeneca buys partner Omniose for bacterial vaccine technology AstraZeneca has acquired vaccine bioconjugation specialist Omniose, securing technology and expertise that could boost its efforts to protect people from bacterial threats. November 10, 2026 FierceBiotech - Biotech Mirum scores again in hepatitis D phase 3, setting the stage for brelovitug’s FDA run Mirum Pharmaceuticals has kept its clinical winning streak alive in hepatitis D, meeting the primary endpoint in another late-stage trial of its antiviral monoclonal antibody brelovitug. November 10, 2026 FierceBiotech - Biotech AbCellera becomes latest biotech to abandon dream of developing OX40 drug AbCellera has become the latest drug developer to abandon its attempts to crack the OX40 code. November 10, 2026 FierceBiotech - Medtech Deerfield Management Partners with Amazon’s AWS for AI drive in life sciences Deerfield Management announced a collaboration with Amazon Web Services (AWS) aiming to accelerate the development and scaling of AI-native healthcare and life sciences companies in its portfolio. November 10, 2026 FierceBiotech - Medtech Novocure denied FDA approval for Optune Mya cancer device after efficacy concerns Novocure has been hit with a relatively rare “not approvable” letter from the FDA for its tumor-treating electric fields device. November 10, 2026 BioSpace - Drug Delivery FDA orders class-wide GLP-1 label update to include potential risk for rare eye disease Twelve marketed drugs, including Eli Lilly’s and Novo’s weight loss mega-blockbusters, will require a label change under the new FDA update. November 9, 2026 BioSpace - Deals Argenx buyout of peptide engine and Big Pharma favorite UNP could top $1B Unnatural Products has risen from founder Joshua Schwochert’s garage to an acquisition deal, valued at up to $1.15 billion, to join argenx. November 9, 2026 FierceBiotech - CRO Rivia launches AI-powered clinical trial data review module, with Scancell as early adopter Swiss data engine Rivia has launched a new AI-powered data review module to speed up clinical data cleaning. November 9, 2026 BioSpace - Drug Delivery Before GMP: Six manufacturing considerations gene therapy sponsors should address earlier SK pharmteco’s Tatiana Nanda, chief technical officer of SK pharmteco Viral Vector North America discusses what gene therapy sponsors must account for sooner rather than later when preparing for GMP... November 9, 2026 BioSpace - Drug Delivery Forge’s Piteri-Molina on AI, Ohio and what’s next for gene therapy manufacturing The BioSpace 40 Under 40 honoree helped steer Forge’s sale to Ajinomoto. Now, Samantha Piteri-Molina sees opportunities in AI-driven analytics and Ohio’s gene therapy ecosystem—with a responsibility to patients worldwide. November 6, 2026 FierceBiotech - Medtech Siemens Healthineers rebrands and carves out in vitro diagnostics biz Siemens Healthineers will carve out its in vitro diagnostics business as a standalone company operating under the name Olyrian Diagnostics. November 6, 2026 BioSpace - Deals Evommune inks molecular glue deal worth $1.1B biobucks to fill pipeline gap Evommune is commiting $30 million upfront for Hinova Pharmaceuticals’ oral molecular glue degrader—a low-cost bet with a high probability of success, according to analysts, after clinical failures roiled the biotech’s... November 5, 2026 BioSpace - Deals Coveted metabolic gem Rhythm reportedly gets $10B offer from AstraZeneca AstraZeneca has apparently made a $10 billion bid to acquire Rhythm Pharmaceuticals, an offer William Blair suspects will not be the last for the hot ticket metabolic biotech. November 5, 2026 BioSpace - Drug Delivery Beyond the needle: The future of intratumoral therapy In this episode of Denatured, you’ll hear from from Lewis Bender, CEO at Intensity Therapeutics and Paul-Peter Tak, president, CEO and board director at Candel Therapeutics. We explore how intratumoral... November 5, 2026 BioSpace - Deals Boehringer bets big on China, offering $7B biobucks for Sino cancer programs Boehringer Ingelheim is building up its China strategy, inking a deal to develop new cancer treatments with Sino Biopharmaceutical just weeks after opening an R&D facility in Shanghai. November 4, 2026 BioSpace - Deals AbbVie bets up to $1.47B for Nxera’s discarded IBD program AbbVie’s $100 million upfront cash payment will purchase global rights to Nxera’s deprioritized oral small molecule, which has already completed Phase 1 testing. November 4, 2026 FierceBiotech - CRO Charles River teams up with Ipsen to use virtual control groups in toxicology studies Charles River Laboratories’ virtual control group (VCG) database will be used in a toxicology study run by French biopharma company Ipsen. November 4, 2026 FierceBiotech - Medtech Blackstone Life Sciences teams up with Boston Scientific in $455M heart pump deal Blackstone Life Sciences has penned a $455 million collaboration with Boston Scientific to co-fund the development of the medtech’s next-generation miniature heart pump system. November 4, 2026 FierceBiotech - CRO nPhase rakes in $30M to expand AI-native clinical data platform Clinical research company nPhase has closed a $30 million series D financing round to expand its AI-native clinical data platform. November 4, 2026 FierceBiotech - Medtech Smith+Nephew held failed talks with J&J over potential orthopedics combination Smith+Nephew held talks with Johnson & Johnson’s hip-and-knee replacement unit DePuy Synthes aimed at a potential combination with its orthopedics unit. November 4, 2026 FierceBiotech - Medtech Insulin pump maker MiniMed names David Segal chief medical officer MiniMed has hired David Segal, M.D., as its new chief medical officer, bringing in a diabetes care and digital health veteran as the company enters its next chapter as an... November 4, 2026 BioSpace - Drug Delivery Lonza agrees to buy 5 Merck KGaA facilities to accelerate US expansion The Swiss contract development and manufacturing organization will more than double its U.S. footprint by acquiring the Merck KGaA plants. November 3, 2026 BioSpace - Drug Delivery Novartis puts $772M BioArctic deal on ice, skates away from brain-delivery alliance Novartis is discontinuing a neurodegeneration alliance with BioArctic in which the companies aimed to develop a drug candidate that could cross the blood-brain barrier. November 3, 2026 FierceBiotech - Medtech Philips sets aside $322M for proposed DOJ settlement over sleep apnea device recall Philips’ Respironics division has reached an “agreement in principle” with the U.S. Department of Justice to settle a long-running investigation into its recall of potentially defective sleep apnea devices. November 3, 2026 FierceBiotech - Medtech GE HealthCare debuts ceiling-mounted AI image guidance system GE HealthCare has debuted Allia Celeo, a ceiling-mounted image guiding system, at the Transcatheter Cardiovascular Therapeutics (TCT) 2026 conference. November 3, 2026 FierceBiotech - Medtech Abbott's Tectonic test looks to shift artery disease treatment with ‘early’ win Abbott has posted positive 30-day results from its Tectonic trial of the investigational SonicForce Coronary IVL System in coronary artery disease (CAD), but analysts urge caution on results. November 3, 2026 BioSpace - Drug Delivery Sun Pharma stops eye-care drug production at Indian plant amid quality issues The cessation of manufacturing activities follows a Sun Pharma recall and reports that regulators found fault with the company’s quality system. November 2, 2026 FierceBiotech - Medtech Bracco invests $230M in first US diagnostic imaging manufacturing facility Bracco announced it will invest $230 million to establish its first U.S. manufacturing facility for injectable contrast media in Sanford, North Carolina. October 30, 2026 FierceBiotech - Medtech Roche launches differential diagnosis test for mesothelioma Roche announced the global launch of its VENTANA BAP1 (SP527) test, an automated, ready-to-use immunohistochemistry (IHC) assay. October 30, 2026 FierceBiotech - Medtech Labcorp continues acquisition spree as it buys up Millennium Health Labcorp is acquiring Millennium Health to boost the medtech giant’s toxicology testing capabilities throughout the U.S. October 27, 2026 FierceBiotech - CRO BMS joins 3-year partnership to boost participation in cancer trials The Institute for Healthcare Improvement has partnered with Bristol Myers Squibb on an initiative to expand access to cancer trials. October 26, 2026 FierceBiotech - CRO Boehringer, Microsoft team up to explore digital patient twins for clinical trials Boehringer Ingelheim and Microsoft have launched a collaboration to explore the use of AI-powered digital patient twins to improve clinical trial design. October 26, 2026 BioSpace - Policy Roche flags ‘final opportunity’ for Germany to reestablish as a reliable investment location Following the withdrawal of billions of dollars in investments from Boehringer Ingelheim and Eli Lilly, German lawmakers have proposed a clause to the country’s healthcare reforms set to take effect... October 23, 2026 FierceBiotech - Medtech EQT buys molecular diagnostics specialist Qiagen in a €10.8B deal EQT is buying up Netherlands-based Qiagen in a deal worth €10.8 billion ($12.1 billion) in enterprise value that includes $1.1 billion in net debt. October 23, 2026 FierceBiotech - Medtech Quest Diagnostics’ test results system breached in yet another medtech cyberattack Quest Diagnostics is the latest life sciences company to fall victim to a cyberattack, with the company believing patient records have been compromised. October 22, 2026 FierceBiotech - Medtech Abbott to separate Nutrition business into an independent, publicly traded company Abbott will separate its Nutrition business into an independent, publicly traded company through a tax-free distribution to Abbott shareholders. October 22, 2026 FierceBiotech - Medtech Myriad Genetics to sell off Prenatal Health testing business to Labcorp Myriad Genetics is selling off its Prenatal Health testing biz to Labcorp for $210 million in cash. October 21, 2026 FierceBiotech - Medtech Hologic snaps up Reveal Genomics to boost genomic diagnostic reach Hologic is acquiring precision oncology company Reveal Genomics. October 21, 2026 FierceBiotech - CRO Advocacy organization launches data dashboard to better assess how clinical trial sites perform The Society for Clinical Research Sites (SCRS) has launched a data intelligence platform to offer fresh insights into how different locations compare. October 20, 2026 FierceBiotech - CRO IQVIA, Veeva expand on existing partnership for speedier clinical trials Clinical research giant IQVIA and cloud system provider Veeva Systems have expanded their partnership to further increase trial speed and efficiency. October 13, 2026 FierceBiotech - CRO WCG unveils AI-powered solution to accelerate clinical trial kickoffs WCG, a clinical trials solutions provider, is launching an AI-powered program dubbed Activation Intelligence to help study sites accelerate clinical trial start-up. October 13, 2026 FierceBiotech - CRO ARPA-H unveils Surpass program to accelerate and expand clinical trials The U.S. Department of Health and Human Services announced the launch of a new program aimed at removing barriers that slow clinical development and transforming how clinical trials are designed... October 7, 2026 BioSpace - Policy US government launches AI-driven programs to overhaul clinical trials Amid rising industry concerns about U.S. competitiveness with China, the Trump administration is rolling out four ARPA-H initiatives to modernize clinical trial design, site activation, consent and patient data collection. October 1, 2026 FierceBiotech - CRO Canadian $5M accelerated clinical trial program cuts start-up to 45 days A newly launched $5 million clinical trial program allows clinical trial sponsors to start trials in as little as 45 days in Ontario. September 29, 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 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 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 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 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 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 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 Load More
