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 PTC takes a chance on Sangamo’s Fabry disease gene therapy Wall Street analysts view the deal as a risky, high-reward bet on a treatment that’s nearing a possible regulatory approval and could be superior to existing medications. August 13, 2026 BioSpace - All News Taiho and Cullinan’s zipalertinib clears Phase 3, teeing up first-line competition Taiho Pharmaceutical and Cullinan Therapeutics’ cancer asset is already under FDA review in a later setting, with a decision expected by February. August 13, 2026 BioSpace - Business Taiho and Cullinan’s zipalertinib clears Phase 3, teeing up first-line competition Taiho Pharmaceutical and Cullinan Therapeutics’ cancer asset is already under FDA review in a later setting, with a decision expected by February. August 13, 2026 BioSpace - Drug Development Taiho and Cullinan’s zipalertinib clears Phase 3, teeing up first-line competition Taiho Pharmaceutical and Cullinan Therapeutics’ cancer asset is already under FDA review in a later setting, with a decision expected by February. August 13, 2026 BioSpace - FDA Taiho and Cullinan’s zipalertinib clears Phase 3, teeing up first-line competition Taiho Pharmaceutical and Cullinan Therapeutics’ cancer asset is already under FDA review in a later setting, with a decision expected by February. August 13, 2026 BioSpace - All News MindMaze trims Relief staff, Aardvark cuts workforce amid Prader-Willi troubles Follow along as BioSpace tracks job cuts and restructuring initiatives. August 13, 2026 BioSpace - Business MindMaze trims Relief staff, Aardvark cuts workforce amid Prader-Willi troubles Follow along as BioSpace tracks job cuts and restructuring initiatives. August 13, 2026 BioSpace - All News Zealand sells milestone, royalty rights to rare blood cancer asset for up to $100M The terms of the agreement with Royalty Pharma suggest the market potential of Zealand Pharma’s polycythemia vera drug candidate may be undervalued, according to Jefferies analysts. August 13, 2026 BioSpace - Business Zealand sells milestone, royalty rights to rare blood cancer asset for up to $100M The terms of the agreement with Royalty Pharma suggest the market potential of Zealand Pharma’s polycythemia vera drug candidate may be undervalued, according to Jefferies analysts. August 13, 2026 BioSpace - Deals Zealand sells milestone, royalty rights to rare blood cancer asset for up to $100M The terms of the agreement with Royalty Pharma suggest the market potential of Zealand Pharma’s polycythemia vera drug candidate may be undervalued, according to Jefferies analysts. August 13, 2026 BioSpace - All News Bankrupt Sangamo offloads assets to Lilly, PTC in $161M sale PTC Therapeutics emerged as the winning bidder over Astellas for Sangamo Therapeutics’ Fabry disease gene therapy, while Eli Lilly is purchasing the biotech’s prion disease program and several platforms. August 13, 2026 BioSpace - Business Bankrupt Sangamo offloads assets to Lilly, PTC in $161M sale PTC Therapeutics emerged as the winning bidder over Astellas for Sangamo Therapeutics’ Fabry disease gene therapy, while Eli Lilly is purchasing the biotech’s prion disease program and several platforms. August 13, 2026 BioSpace - Deals Bankrupt Sangamo offloads assets to Lilly, PTC in $161M sale PTC Therapeutics emerged as the winning bidder over Astellas for Sangamo Therapeutics’ Fabry disease gene therapy, while Eli Lilly is purchasing the biotech’s prion disease program and several platforms. August 13, 2026 BioSpace - All News The Italian inflection point: Clinical strength, culture and capital In this episode of Denatured, you’ll hear from Diana Saraceni, founder and managing partner at Panakès Partners and Fabrizio Calisti, medical director at Angelini Ventures. We explore how Italy’s life... August 13, 2026 BioSpace - Drug Development The Italian inflection point: Clinical strength, culture and capital In this episode of Denatured, you’ll hear from Diana Saraceni, founder and managing partner at Panakès Partners and Fabrizio Calisti, medical director at Angelini Ventures. We explore how Italy’s life... August 13, 2026 FierceBiotech - Main PDS halts work on phase 3 cancer therapy to focus on colorectal contender PDS Biotechnology has called time on its phase 3 head and neck cancer therapy to channel resources to a drug in phase 2 development for metastatic colorectal cancer. August 13, 2026 FierceBiotech - Biotech PDS halts work on phase 3 cancer therapy to focus on colorectal contender PDS Biotechnology has called time on its phase 3 head and neck cancer therapy to channel resources to a drug in phase 2 development for metastatic colorectal cancer. August 13, 2026 FierceBiotech - Main PTC’s $211M bid wins Sangamo auction, teeing up ‘special opportunity’ to enter Fabry market PTC Therapeutics has struck a deal to buy Sangamo Therapeutics’ Fabry disease program for $111 million upfront, outbidding Astellas and TerSera Therapeutics for the near-approval gene therapy. Sangamo, selling assets... August 13, 2026 FierceBiotech - Biotech PTC’s $211M bid wins Sangamo auction, teeing up ‘special opportunity’ to enter Fabry market PTC Therapeutics has struck a deal to buy Sangamo Therapeutics’ Fabry disease program for $111 million upfront, outbidding Astellas and TerSera Therapeutics for the near-approval gene therapy. Sangamo, selling assets... August 13, 2026 BioSpace - All News Behind the bell: Gearing up to go public Avalyn Pharma and Generate Biomedicines executives discuss the long hours, hard work and rewarding moments of taking their companies public. August 13, 2026 BioSpace - All News July's biopharma layoffs affect 466 employees, a 94% year-over-year drop Last month, biopharmas cutting or planning to cut their workforces included Amgen, GSK and Novartis, with Novartis’ layoffs affecting the most people. August 13, 2026 BioSpace - Business Behind the bell: Gearing up to go public Avalyn Pharma and Generate Biomedicines executives discuss the long hours, hard work and rewarding moments of taking their companies public. August 13, 2026 BioSpace - Business July's biopharma layoffs affect 466 employees, a 94% year-over-year drop Last month, biopharmas cutting or planning to cut their workforces included Amgen, GSK and Novartis, with Novartis’ layoffs affecting the most people. August 13, 2026 FierceBiotech - Main Cullinan tees up J&J fight—and $100M payday—as Taiho-partnered drug hits phase 3 cancer goal Taiho Pharmaceutical and Cullinan Therapeutics have celebrated a second phase 3 victory for their small-molecule EGFR inhibitor, teeing the partners up to challenge Johnson & Johnson for a lung cancer... August 13, 2026 FierceBiotech - Biotech Cullinan tees up J&J fight—and $100M payday—as Taiho-partnered drug hits phase 3 cancer goal Taiho Pharmaceutical and Cullinan Therapeutics have celebrated a second phase 3 victory for their small-molecule EGFR inhibitor, teeing the partners up to challenge Johnson & Johnson for a lung cancer... August 13, 2026 FierceBiotech - Main Zealand sells its rights to Takeda’s blood cancer drug for $100M ahead of FDA approval decision As the FDA mulls whether to approve Takeda and Protagonist Therapeutics’ rusfertide, Zealand Pharma has sold its own rights to the blood cancer drug in return for $100 million. August 13, 2026 FierceBiotech - Biotech Zealand sells its rights to Takeda’s blood cancer drug for $100M ahead of FDA approval decision As the FDA mulls whether to approve Takeda and Protagonist Therapeutics’ rusfertide, Zealand Pharma has sold its own rights to the blood cancer drug in return for $100 million. August 13, 2026 FierceBiotech - Main Medtronic veteran Bill Shields crosses over to become CEO at valve disease startup After 15 years with Medtronic’s structural heart franchise, Bill Shields is leaving the medtech giant to become the chief executive of startup Versa Vascular. August 13, 2026 FierceBiotech - Medtech Medtronic veteran Bill Shields crosses over to become CEO at valve disease startup After 15 years with Medtronic’s structural heart franchise, Bill Shields is leaving the medtech giant to become the chief executive of startup Versa Vascular. August 13, 2026 FierceBiotech - Main Pfizer’s former chemistry whiz debuts Khartis Therapeutics with $95M for thyroid eye disease pill Three years after Robert Hoffman sold XinThera to Gilead, the veteran Pfizer chemist has unveiled his latest venture. August 12, 2026 FierceBiotech - Biotech Pfizer’s former chemistry whiz debuts Khartis Therapeutics with $95M for thyroid eye disease pill Three years after Robert Hoffman sold XinThera to Gilead, the veteran Pfizer chemist has unveiled his latest venture. August 12, 2026 BioPharma Dive Lilly files six lawsuits in bid to shut down ‘black market’ for retatrutide Ahead of an approval filing, the drugmaker is amping up a fight against sellers who claim to offer versions of its highly anticipated “triple-G” weight loss medicine. August 12, 2026 BioSpace - All News Deaths reported after treatment with Neurocrine’s approved Prader-Willi drug Reports of seven deaths in patients who had taken Neurocrine Biosciences’ Vykat and the official termination of Aardvark Therapeutics’ Phase 3 trial after cardiac complications marked a tough day for... August 12, 2026 BioSpace - Business Deaths reported after treatment with Neurocrine’s approved Prader-Willi drug Reports of seven deaths in patients who had taken Neurocrine Biosciences’ Vykat and the official termination of Aardvark Therapeutics’ Phase 3 trial after cardiac complications marked a tough day for... August 12, 2026 BioSpace - Drug Development Deaths reported after treatment with Neurocrine’s approved Prader-Willi drug Reports of seven deaths in patients who had taken Neurocrine Biosciences’ Vykat and the official termination of Aardvark Therapeutics’ Phase 3 trial after cardiac complications marked a tough day for... August 12, 2026 BioPharma Dive Psychedelics developer Definium scores more positive data for LSD pill Results from a late-stage study focused on generalized anxiety disorder were a “clean win” to analysts, who believe Definium has a drug with multibillion-dollar sales potential. August 12, 2026 BioSpace - All News 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. August 12, 2026 BioSpace - Business 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. August 12, 2026 BioSpace - Drug Development 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. August 12, 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. August 12, 2026 BioSpace - All News Definium’s LSD asset beats analyst expectations in Phase 3 anxiety readout It’s smooth sailing for Definium Therapeutics as the psychedelic biotech charts another win for its LSD candidate, this time in anxiety. The psychedelic previously notched a late-stage victory in depression. August 12, 2026 BioSpace - Business Definium’s LSD asset beats analyst expectations in Phase 3 anxiety readout It’s smooth sailing for Definium Therapeutics as the psychedelic biotech charts another win for its LSD candidate, this time in anxiety. The psychedelic previously notched a late-stage victory in depression. August 12, 2026 BioSpace - Drug Development Definium’s LSD asset beats analyst expectations in Phase 3 anxiety readout It’s smooth sailing for Definium Therapeutics as the psychedelic biotech charts another win for its LSD candidate, this time in anxiety. The psychedelic previously notched a late-stage victory in depression. August 12, 2026 FierceBiotech - Main 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 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 - All News Lilly cracks down on black market for obesity asset retatrutide with six lawsuits Beyond the legal action, Eli Lilly is calling on healthcare providers, regulatory authorities, online platforms and even logistics companies to help stem the illegal sale of its next-generation asset for... August 12, 2026 BioSpace - Business Lilly cracks down on black market for obesity asset retatrutide with six lawsuits Beyond the legal action, Eli Lilly is calling on healthcare providers, regulatory authorities, online platforms and even logistics companies to help stem the illegal sale of its next-generation asset for... August 12, 2026 BioSpace - All News 7 companies hiring in North Carolina now Looking for a biopharma job in North Carolina? Job postings in the area have increased. Here are seven companies with open roles. August 12, 2026 BioPharma Dive Silence cashes in on ‘differentiated’ data; UK reaffirms support for childhood vaccines Some analysts believe Silence’s polycythemia vera drug could be superior to a closely watched Takeda medicine. Elsewhere, the FDA spurned a radiopharmaceutical and AbCellera shares climbed to levels not seen... August 12, 2026 BioSpace - All News Sentynl bets up to $475M in licensing deal for Mereo’s rare lung disease asset Mereo BioPharma’s asset, dubbed alvelestat, is set to enter Phase 3 development for AATD-LD in 2027. August 12, 2026 BioSpace - Deals Sentynl bets up to $475M in licensing deal for Mereo’s rare lung disease asset Mereo BioPharma’s asset, dubbed alvelestat, is set to enter Phase 3 development for AATD-LD in 2027. August 12, 2026 BioSpace - All News BridgeBio continues ATTR ascent as Alnylam’s Amvuttra falls short of expectations BridgeBio Pharma’s transthyretin amyloidosis medicine Attruby is off to a strong launch, while Alnylam lowered full-year sales guidance for competitor Amvuttra. August 12, 2026 BioPharma Dive Boulevard starts up with $65M to pursue targeted autoimmune drugs Co-founded by pioneering researcher Georg Schett and ex-Sanofi CSO Frank Nestle, the startup is advancing a trio of multifaceted antibodies with the potential to treat several immune diseases. August 12, 2026 BioSpace - All News Replimune finally wins approval, Q2 earnings wrap up, psychedelics stay in spotlight After two rejections, Replimune has made it across the regulatory finish line with its advanced melanoma therapy. Meanwhile, the last of the major pharmas, including Eli Lilly and Novo Nordisk,... August 12, 2026 BioSpace - Drug Development Replimune finally wins approval, Q2 earnings wrap up, psychedelics stay in spotlight After two rejections, Replimune has made it across the regulatory finish line with its advanced melanoma therapy. Meanwhile, the last of the major pharmas, including Eli Lilly and Novo Nordisk,... August 12, 2026 BioSpace - FDA Replimune finally wins approval, Q2 earnings wrap up, psychedelics stay in spotlight After two rejections, Replimune has made it across the regulatory finish line with its advanced melanoma therapy. Meanwhile, the last of the major pharmas, including Eli Lilly and Novo Nordisk,... August 12, 2026 FierceBiotech - Main After slimming down workforce, Aardvark scraps phase 3 trials as wait for next steps drags on Aardvark Therapeutics has confirmed it is walking away from recently terminated phase 3 trials, telling investors it has no plans to resume the studies “as previously designed” as it works... August 12, 2026 FierceBiotech - Biotech After slimming down workforce, Aardvark scraps phase 3 trials as wait for next steps drags on Aardvark Therapeutics has confirmed it is walking away from recently terminated phase 3 trials, telling investors it has no plans to resume the studies “as previously designed” as it works... August 12, 2026 FierceBiotech - Main Samsung hearing aid features for its ear buds garner FDA clearance The FDA gave Samsung Electronics the go-ahead for the latest software features that allow its Galaxy Buds earphones to act as an OTC hearing aid that also allows users to... August 12, 2026 FierceBiotech - Medtech Samsung hearing aid features for its ear buds garner FDA clearance The FDA gave Samsung Electronics the go-ahead for the latest software features that allow its Galaxy Buds earphones to act as an OTC hearing aid that also allows users to... August 12, 2026 BioSpace - All News Why a missed promotion isn't always about you A missed promotion can feel like a verdict on your potential. But people and organizations do not always develop at the same pace. Executive coach Angela Justice breaks down what... August 12, 2026 BioSpace - All News With tech backing, AI biotechs force biopharma into ‘fail-fast’ drug development AI is quickly becoming a central force in drug development, from powering pharma engines to permanently rewiring the capital markets. August 12, 2026 FierceBiotech - Main CytoDyn’s leronlimab reaffirms HIV potential after combo treatment eradicates virus in infant macaques CytoDyn's leronlimab may have struggled to secure approval as an HIV treatment, but research in infant primates has offered fresh hope for the CCR5-targeting antibody's ability to treat the virus. August 11, 2026 FierceBiotech - Main Definium hits another phase 3 homerun with psychedelic ‘sea change’ for anxiety Definium Therapeutics’ LSD formula has gone two for two in its phase 3 program, notching a win in generalized anxiety disorder months after knocking a depression study out of the... August 11, 2026 FierceBiotech - Biotech Definium hits another phase 3 homerun with psychedelic ‘sea change’ for anxiety Definium Therapeutics’ LSD formula has gone two for two in its phase 3 program, notching a win in generalized anxiety disorder months after knocking a depression study out of the... August 11, 2026 BioPharma Dive Ex-Legend CEO takes helm at biotech startup scouring the globe for drugs Ying Huang is now running K2 Therapeutics, which has licensed multiple prospects from China-based biotechs and is searching for more “high-potential” medicines. August 11, 2026 BioSpace - All News FDA rejects ITM Isotope’s radiopharma therapy over manufacturing issues ITM Isotope Technologies plans on resubmitting its advanced cancer radiopharma therapy to the FDA after addressing the agency’s concerns. August 11, 2026 BioSpace - FDA FDA rejects ITM Isotope’s radiopharma therapy over manufacturing issues ITM Isotope Technologies plans on resubmitting its advanced cancer radiopharma therapy to the FDA after addressing the agency’s concerns. August 11, 2026 BioSpace - Drug Delivery FDA rejects ITM Isotope’s radiopharma therapy over manufacturing issues ITM Isotope Technologies plans on resubmitting its advanced cancer radiopharma therapy to the FDA after addressing the agency’s concerns. August 11, 2026 FierceBiotech - Main Amgen lays groundwork for new R&D center in Hyderabad Amgen is expanding its footprint in India with an R&D center in Hyderabad, the latest by from the California company to boost its research facilities. August 11, 2026 FierceBiotech - Biotech Amgen lays groundwork for new R&D center in Hyderabad Amgen is expanding its footprint in India with an R&D center in Hyderabad, the latest by from the California company to boost its research facilities. August 11, 2026 BioPharma Dive Chasing Dupixent, a biotech aims to make better antibody drugs for eczema Infinimmune, a California startup, is developing treatments it claims might last longer and be more effective than existing atopic dermatitis medications. August 11, 2026 FierceBiotech - Main Deerfield-backed Boulevard Bio embarks on ‘beautiful path to a cure’ with trio of immunology drugs Boulevard Bio has strolled out of stealth with $65 million in funding from Deerfield Management and three autoimmune disease candidates. August 11, 2026 FierceBiotech - Biotech Deerfield-backed Boulevard Bio embarks on ‘beautiful path to a cure’ with trio of immunology drugs Boulevard Bio has strolled out of stealth with $65 million in funding from Deerfield Management and three autoimmune disease candidates. August 11, 2026 BioSpace - All News Scholar Rock rejigs approval filing after FDA flags violations at Novo plant Despite earlier claims of improvement at the fill-finish plant, the FDA has classified the facility as Official Action Indicated based on inspection findings. August 11, 2026 BioSpace - Drug Development Scholar Rock rejigs approval filing after FDA flags violations at Novo plant Despite earlier claims of improvement at the fill-finish plant, the FDA has classified the facility as Official Action Indicated based on inspection findings. August 11, 2026 BioSpace - FDA Scholar Rock rejigs approval filing after FDA flags violations at Novo plant Despite earlier claims of improvement at the fill-finish plant, the FDA has classified the facility as Official Action Indicated based on inspection findings. August 11, 2026 BioSpace - Drug Delivery Scholar Rock rejigs approval filing after FDA flags violations at Novo plant Despite earlier claims of improvement at the fill-finish plant, the FDA has classified the facility as Official Action Indicated based on inspection findings. August 11, 2026 BioSpace - All News After billions in deals, Insilico CEO promises: ‘You haven't seen anything yet’ Insilico Medicine CEO Alex Zhavoronkov’s mad dash across the BIO International Convention in June attracted plenty of eyes. But the executive would prefer industry watchers gawk at the billions of... August 11, 2026 BioSpace - Deals After billions in deals, Insilico CEO promises: ‘You haven't seen anything yet’ Insilico Medicine CEO Alex Zhavoronkov’s mad dash across the BIO International Convention in June attracted plenty of eyes. But the executive would prefer industry watchers gawk at the billions of... August 11, 2026 BioPharma Dive Epicrispr lands $90M to advance epigenetic editing drug for rare muscle disease The startup has completed enrollment of an early-stage study testing a first-of-its-kind treatment for facioscapulohumeral muscular dystrophy, a disease targeted by many other drugmakers. August 11, 2026 BioPharma Dive Trump signs order seeking to upend childhood vaccine schedule The executive order — which wasn’t accompanied by any new scientific evidence — aims to split the MMR vaccine into three separate shots and revives the administration’s attempt to slim down the... August 11, 2026 BioSpace - Drug Development AbCellera’s menopause medicine ‘sets new efficacy bar’ for hot flashes AbCellera Biologics’ reduction in hot flashes sets it apart from currently commercial oral drugs, including Astellas’ Veozah and Bayer’s Lynkuet, according to BMO Capital Markets. August 11, 2026 BioSpace - Drug Development Silence causes uproar in rare blood cancer space as data sets high bar for competitors The mid-stage win of Silence Therapeutics’ siRNA drug in polycythemia vera validates the therapeutic approach of similar assets in development—but also sets a high standard for therapies from Takeda, Agios... August 11, 2026 BioPharma Dive Vaderis hauls in $152M to test an AKT-targeting drug The startup is one of at least a few young companies zeroing in on the rare bleeding disorder, hereditary hemorrhagic telangiectasia, with a more precise AKT blocker. August 11, 2026 FierceBiotech - Main Epicrispr raises $90M to rewrite treatment of rare muscle disease Epicrispr Biotechnologies has raised $90 million in a series C round backed by investors including Sanofi Ventures, positioning the biotech to advance a pipeline of epigenetic medicines led by an... August 11, 2026 FierceBiotech - Biotech Epicrispr raises $90M to rewrite treatment of rare muscle disease Epicrispr Biotechnologies has raised $90 million in a series C round backed by investors including Sanofi Ventures, positioning the biotech to advance a pipeline of epigenetic medicines led by an... August 11, 2026 FierceBiotech - Main Zydus’ Sentynl pens $475M deal for Mereo’s phase 3-ready rare genetic lung disease drug Sentynl Therapeutics has penned a deal potentially worth $475 million for the option to market Mereo BioPharma's phase 3-ready rare genetic respiratory disease drug in the U.S. August 11, 2026 FierceBiotech - Biotech Zydus’ Sentynl pens $475M deal for Mereo’s phase 3-ready rare genetic lung disease drug Sentynl Therapeutics has penned a deal potentially worth $475 million for the option to market Mereo BioPharma's phase 3-ready rare genetic respiratory disease drug in the U.S. August 11, 2026 FierceBiotech - Main After tasting IPO success, Hemab’s CEO seeks ‘flavor of a multi-product coagulation company’ With the post-IPO quiet period having come to an end, CEO Benny Sørensen, M.D., Ph.D., was free to sit down with Fierce to map out Hemab’s future. August 11, 2026 FierceBiotech - Biotech After tasting IPO success, Hemab’s CEO seeks ‘flavor of a multi-product coagulation company’ With the post-IPO quiet period having come to an end, CEO Benny Sørensen, M.D., Ph.D., was free to sit down with Fierce to map out Hemab’s future. August 11, 2026 FierceBiotech - Main Aura lays off 20% of workforce, rejigs C-suite amid R&D refocus on eye cancer Aura Biosciences is refocusing under its recently installed CEO, laying off 20% of its employees and overhauling its C-suite as it narrows its focus on ocular oncology. August 11, 2026 FierceBiotech - Biotech Aura lays off 20% of workforce, rejigs C-suite amid R&D refocus on eye cancer Aura Biosciences is refocusing under its recently installed CEO, laying off 20% of its employees and overhauling its C-suite as it narrows its focus on ocular oncology. August 11, 2026 BioSpace - Drug Development Austria’s new growth fund could further bolster its dynamic biotech innovation economy The national growth vehicle isn’t biotech‑dedicated, but channeling capital toward life sciences would amplify Austria’s strong research hubs, nondilutive funding landscape and reputation as a champion in science and technology. August 11, 2026 FierceBiotech - Main Abbott teams with Google Health on AI-powered health insights app Two giants of their respective fields, Abbott and Google, are joining forces for a first-of-its-kind team-up that aims to build out a digital picture of people’s health. August 11, 2026 FierceBiotech - Medtech Abbott teams with Google Health on AI-powered health insights app Two giants of their respective fields, Abbott and Google, are joining forces for a first-of-its-kind team-up that aims to build out a digital picture of people’s health. August 11, 2026 BioSpace - Drug Delivery BMS picks Texas for new $2.3B manufacturing campus Bristol Myers Squibb’s $2.3 billion Houston manufacturing campus is part of the company’s larger $40 billion investment designed to bolster American innovation and manufacturing. August 10, 2026 FierceBiotech - Main Regeneron backs $75M series A for antibody upstart Infinimmune Infinimmune has amassed further fuel to power its antibody discovery engine, netting a $75 million series A headlined by Regeneron’s venture arm. August 10, 2026 FierceBiotech - Biotech Regeneron backs $75M series A for antibody upstart Infinimmune Infinimmune has amassed further fuel to power its antibody discovery engine, netting a $75 million series A headlined by Regeneron’s venture arm. August 10, 2026 BioSpace - Deals Jazz commits up to $1.3B to buy Actio, bolster epilepsy pipeline Jazz Pharmaceuticals is reaching into its wallet once again, this time buying Actio Biosciences and an experimental therapy for KCNT1+ epilepsy, a form of the disease with no FDA-approved treatments. August 10, 2026 BioSpace - FDA All eyes on psychedelic drugmakers as Definium, Compass near major catalysts Definium Therapeutics’ closely watched anxiety readout could further validate its single-dose LSD candidate, while Compass Pathways advances a psilocybin program through a rolling FDA filing. August 10, 2026 BioSpace - Deals AstraZeneca partners with CSPC to build Chinese biologics manufacturing plant News of the joint venture comes months after AstraZeneca vowed to spend $15 billion in China by the end of the decade. August 10, 2026 BioSpace - Drug Delivery AstraZeneca partners with CSPC to build Chinese biologics manufacturing plant News of the joint venture comes months after AstraZeneca vowed to spend $15 billion in China by the end of the decade. August 10, 2026 FierceBiotech - Main ‘We are proud to be in the lead’: Vaderis lands $152M for phase 3 study in rare blood vessel disorder Vaderis Therapeutics has secured an oversubscribed $152 million series B financing to propel the Swiss biotech's AKT inhibitor through phase 3 with the aim of bringing the first treatment for... August 10, 2026 FierceBiotech - Biotech ‘We are proud to be in the lead’: Vaderis lands $152M for phase 3 study in rare blood vessel disorder Vaderis Therapeutics has secured an oversubscribed $152 million series B financing to propel the Swiss biotech's AKT inhibitor through phase 3 with the aim of bringing the first treatment for... August 10, 2026 FierceBiotech - Biotech MoonLake’s nanobody boosts all clinical endpoints in phase 3 psoriatic arthritis trial MoonLake Immunotherapeutics announced positive phase 3 data for patients with psoriatic arthritis treated with its lead nanobody candidate, sonelokimab. August 10, 2026 FierceBiotech - Biotech Jazz pays $820M to buy Actio, adding clinical-stage asset to orchestra of epilepsy therapies Jazz Pharmaceuticals is adding to its orchestra of epilepsy treatments with the acquisition of Actio Biosciences for $820 million upfront. August 10, 2026 FierceBiotech - Biotech Sionna’s cystic fibrosis flop sends stock down 90%, but a ‘significant positive’ for Vertex Sionna Therapeutics has axed a cystic fibrosis add-on program after flunking a phase 2 trial, eliminating a would-be challenger to Vertex Pharmaceuticals’ empire. The biotech plans to “take actions to... August 10, 2026 FierceBiotech - Biotech AbCellera women’s health data top ‘most aggressive upside scenario,’ putting Astellas and Bayer on notice AbCellera has reported phase 2 results “beyond even the most aggressive upside scenario” that its CEO dared to consider, boosting the biotech’s chances of challenging Astellas and Bayer for a... August 10, 2026 FierceBiotech - Medtech Labcorp nabs FDA green light for BRAF melanoma diagnostic The FDA has signed off on Labcorp’s companion diagnostic for patients with advanced melanoma carrying certain BRAF variants. August 10, 2026 FierceBiotech - Medtech FDA issues alert in wake of BD recall of faulty needle sets The FDA’s Center for Devices and Radiological Health issued an early alert for Becton Dickinson’s Intraosseous Vascular Access system needle sets in the wake of four deaths and 45 serious injuries... August 10, 2026 FierceBiotech - Biotech Sobi pens $580M deal for Innate’s skin cancer drug ahead of phase 3 push Sobi has bought into Innate Pharma’s vision for lacutamab, handing the French biotech $75 million upfront for the rights to market the anti-KIR3DL2 antibody for an aggressive skin cancer. August 10, 2026 BioSpace - Drug Delivery From ex vivo to in vivo: Shaping the next generation of viral vector manufacturing The shift from ex vivo to in vivo gene delivery is rewriting the rules of viral vector manufacturing, forcing developers to rethink scale, purity, cell lines and analytics as vectors... August 10, 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 - Medtech Roche adds cyclospora PCR tests as outbreak widens Roche is launching new tests for cyclospora as an outbreak linked to iceberg lettuce from Mexico continues to spread across U.S. states. August 7, 2026 BioSpace - FDA Third time’s the charm for Replimune as melanoma drug earns FDA greenlight Replimune’s immunotherapy for advanced melanoma faced a perilous regulatory road with two previous rejections, but the drug—to be marketed as Tudriqev—prevailed with strong support from oncologists and a 10-3 advisory... August 6, 2026 BioSpace - Deals Braveheart pumps more life into biotech IPO market with $382M expected debut Braveheart Bio has emerged on the Nasdaq with an upsized expected initial public offering—marking the public entrance of the twenty-second biotech this year. August 6, 2026 BioSpace - FDA Takeda’s narcolepsy nod opens orexin doors Orzeyful is the first orexin agonist cleared by the FDA, and is the first narcolepsy therapy that addresses the full host of disease symptoms. It is "likely to reshape the... August 6, 2026 BioSpace - FDA Moderna’s flu shot crosses FDA finish line, bouncing back from regulatory roadblock The FDA in February slapped Moderna’s vaccine with a refusal-to-file letter—though the agency backtracked a few days later and accepted a revised submission for review. An advisory committee in June... August 6, 2026 FierceBiotech - Medtech PacBio CEO steps down amid layoffs, widening Q2 loss PacBio has promoted an internal veteran to CEO after Christian Henry stepped down, tasking the new leader with improving sales, expanding the DNA sequencing company’s clinical reach and cutting costs. August 6, 2026 BioSpace - FDA Lilly, FDA retatrutide biologic dispute comes to a head as submission nears A legal dispute between the FDA and Eli Lilly over whether the highly anticipated obesity candidate retatrutide is indeed a biologic has come to a head as the company prepares... August 5, 2026 BioSpace - Deals No deal between AstraZeneca and BMS, senior source insists: Reuters Reuters has deflated rumors that AstraZeneca and Bristol Myers Squibb are discussing a possible merger, letting the air out of industry-wide speculation over what could have been the largest deal... August 5, 2026 BioSpace - FDA Chaotic adcomms threaten to derail FDA’s bid to renew trust after Makary, Prasad The FDA has been trying to mend fences with rare disease drug developers and patient groups since the departure of former Commissioner Marty Makary three months ago. But advisory committee... August 5, 2026 BioSpace - Deals 4 potential biotech M&A targets, plus a pretty sure bet from J&J Pharma is definitely interested in making more deals. But what biotechs will come under the magnifying glass? BioSpace takes a look at companies that analysts see as near-term targets for... August 5, 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 - Medtech Smith & Nephew cuts 2026 outlook as US knee implant sales slide Smith & Nephew has lowered its 2026 sales outlook after weakness in U.S. orthopedics and wound care outweighed stronger growth in sports medicine. August 4, 2026 FierceBiotech - Medtech KKR inks $5.7B deal to take medtech manufacturing giant Integer private Private equity giant KKR is expanding its healthcare portfolio with a deal to take medtech manufacturing giant Integer private for approximately $5.7 billion. August 4, 2026 FierceBiotech - Medtech Curium strikes up to $8B deal for radiopharma rival Lantheus Months after reports first linked Curium to a potential Lantheus takeover, the radiopharma players have made it official with a deal worth up to $8 billion. August 3, 2026 BioSpace - Drug Delivery Biologics push CMOs/CDMOs to expand sterile fill-finish and prefilled syringe capacity As biologics, biosimilars and GLP-1s drive demand for sterile drug products, CMOs and CDMOs are investing in fill-finish, lyophilization, inspection and packaging capacity to keep pace with a dynamic injectable... August 3, 2026 FierceBiotech - Medtech Labcorp posts higher Q2 earnings on strength of diagnostics, lab services; adjusts full-year guidance Labcorp continues to power along as it posts strong quarterly earnings led by growth in its diagnostics and lab services and triggering the medtech to raise its full-year guidance. July 30, 2026 FierceBiotech - Medtech GSK pens $110M biological datasets pact with AI biotech Relation GSK is boosting its AI chops with a new deal worth up to $110 million with Relation. July 30, 2026 FierceBiotech - Medtech Boston Scientific cuts guidance again after unveiling restructuring plan Boston Scientific is cutting its financial guidance for the second quarter in a row as it gears up for a tough six months ahead. July 30, 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 FierceBiotech - Medtech Guardant Health taps Patrick Dempsey for emotional colorectal cancer awareness video Colorectal cancer blood test maker Guardant Health has teamed up with “Grey’s Anatomy” star Patrick Dempsey for a new, highly emotional video. July 28, 2026 FierceBiotech - Medtech Boston Scientific unveils major restructuring, plots job cuts amid savings drive Medical device maker Boston Scientific has been a prolific dealmaker this year but is now taking a step back as it looks to make changes internally. July 28, 2026 FierceBiotech - Medtech FDA approves Freenome colorectal cancer blood test to be marketed by Abbott The FDA has approved Freenome’s new blood-based colorectal cancer test, SimpleScreen CRC, which Abbott will exclusively market in the U.S. July 27, 2026 FierceBiotech - Medtech Labcorp launches DTC ‘Genetic Health Panel’ to seek out multiple diseases Labcorp is launching the Marker by Labcorp Genetic Health Panel, a new direct-to-consumer genetic testing tool that analyzes 163 genes to determine patients’ risk of over 100 hereditary health conditions. July 27, 2026 FierceBiotech - Medtech Roche Diagnostics growth remains muted amid China headwinds Roche’s Diagnostics division continues to battle growth headwinds, notching a 3% increase in sales. July 23, 2026 FierceBiotech - Medtech FDA clears Johnson & Johnson’s surgical robot for ‘the next era in surgery’ The FDA has authorized Johnson & Johnson’s Ottava Robotic Surgical System as the company looks to compete with Intuitive Surgical and Medtronic. July 23, 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 - Medtech Roche taps Foundation Medicine’s chief as new North America Diagnostics lead, creates new commercial role Dan Malarek is leaving his role as chief executive of Roche’s sequencing subsidiary Foundation Medicine as he takes up the mantle as President and CEO of Roche Diagnostics North America. July 21, 2026 BioSpace - Policy FDA’s radical transparency policy for rejections runs into legal uncertainty Having started to publish CRLs without consulting the public, the FDA is under pressure to change course amid concerns it failed to openly and fully evaluate a complex issue. July 20, 2026 BioSpace - Policy FDA’s first AI-focused cGMP warning letter signals new scrutiny for manufacturers The FDAs enforcement action against Purolea Cosmetics Lab offers an early look at how the agency expects AI-generated work to fit within existing quality systems, with experts saying human oversight... July 16, 2026 BioSpace - Drug Delivery Merck dives into cholesterol with first FDA approval for oral PCSK9 inhibitor Merck’s once-daily pill is the first oral PCSK9 inhibitor to hit the market for high cholesterol, beating AstraZeneca in the race to develop more accessible treatment options. July 16, 2026 BioSpace - Policy Final psychedelics guidance suggests FDA is 'receptive' to helping companies succeed The agency’s finalized recommendations for clinical testing of psychedelic compounds for mental health could pave the way for companies like Compass Pathways, whose psilocybin-based therapy for treatment-resistant depression could win... July 14, 2026 BioSpace - Policy FDA proposes streamlined requirements for ‘hub-and-spoke’ manufacturing models Through the proposal, the FDA could clear barriers to distributed manufacturing approaches intended to enhance emergency preparedness and supply chain resilience. July 14, 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 BioSpace - Policy Biotech’s China problem: An issue of national security or economic value for the US? Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas' clinical trials in China highlight an ongoing discrepancy in... July 2, 2026 BioSpace - Policy Eli Lilly and Regeneron among 7 companies picked for FDA PreCheck pilot program Teams at facilities being developed by Eli Lilly, Regeneron and other companies will receive early technical guidance and additional perks from the FDA. July 1, 2026 BioSpace - Drug Delivery FDA rejects Unicycive and Sobi filings over contract manufacturing deficiencies Unicycive Therapeutics and Sobi received complete response letters for kidney disease and gout filings, respectively, after the FDA found fault with their manufacturing partners. June 30, 2026 BioSpace - Policy BIO 2026: FDA’s IND initiative is a step toward normalization after slipshod year Policymaking at FDA has been anything but business as usual under the Trump administration, but former regulators cite the agency’s new investigational new drug pilot program as a sign of... June 25, 2026 BioSpace - Drug Delivery Labs see rising demand for nitrosamine, topical performance and microbiome testing Recent BioSpace industry conference conversations point to sponsors pushing earlier on safety, quality and performance data, leading to demand for nitrosamine analysis, IVRT/IVPT and microbiome database capabilities. June 25, 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 BioSpace - Policy REGENXBIO bets on FDA flexibility with filing plans for Duchenne gene therapy A few short days after announcing an FDA pivot on a separate asset, REGENXBIO is planning to test the agency’s apparent newfound rare disease outlook on another late-stage gene therapy. June 24, 2026 BioSpace - Drug Delivery BIO 2026: Cell and gene therapy sector must break the mold to thrive If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers... June 22, 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 FierceBiotech - CRO Icon opens early-phase research unit in San Antonio, plus satellite clinics to grow trial capabilities Global contract research organization Icon has announced the opening of a new research facility in San Antonio, Texas, along with satellite clinics in Houston and Lawrence, Kansas, to expand its... May 13, 2026 FierceBiotech - CRO Banyan BioInnovations puts down roots with $100M, Icon partnership Banyan BioInnovations is debuting with more than $100 million aimed at developing NewCos around promising clinical assets, plus a partnership with global contract research organization Icon. May 7, 2026 FierceBiotech - CRO Bipartisan PRIMATE Act aims to ban monkey imports to US A new bipartisan bill could end the import of primates for U.S. research, targeting the roughly 20,000 monkeys brought into the country each year for laboratories or their suppliers. May 6, 2026 FierceBiotech - CRO WCG acquires The Contract Network in bid to streamline clinical trial execution Clinical trials solutions provider WCG is acquiring tech company The Contract Network to improve alignment and decision-making across clinical trial initiation. April 24, 2026 FierceBiotech - CRO FDA celebrates progress to end animal testing but experts warn there’s still a long way to go The FDA says it has hit the one-year goals of its roadmap for ending animal testing. Experts are split on how impactful the agency's actions will be. April 19, 2026 FierceBiotech - CRO RyghtAI launches clinical site search engine to aid drug developers, CROs with trial design Clinical site selection platform RyghtAI has launched a search engine designed to give drug developers and contract research organizations access to a comprehensive database of clinical research sites. April 16, 2026 Load More
