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807 stories matching this filter · ← front page

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  • Lancaster County emerges as new biotech hub as Boston faces layoffs
    Boston’s biotech sector is experiencing layoffs and vacant lab space, signaling a slowdown in the region that has long been a biotech stronghold. In contrast, Lancaster County, Pennsylvania, is wi…
    BioPharma Dive · 4mo agoNeutral↗ source
  • Roche’s divarasib shows survival benefit over Amgen and BMS drugs in KRAS G12C lung cancer trial
    Roche reported that its experimental KRAS G12C inhibitor divarasib extended overall survival and progression‑free survival in a Phase 3 head‑to‑head study against Amgen’s Lumakra and Bristol Myers…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
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fda medwatch112
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Endocrinology & Metabolism782
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Nephrology764
  • Celea Therapeutics raises $180 million to advance next-generation IPF drug deupirfenidone
    Celea Therapeutics, a PureTech Health spinout, announced a $180 million venture round to fund development of its next-generation idiopathic pulmonary fibrosis (IPF) therapy, deupirfenidone. The ro…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Abiomed recalls Impella CP Sets with SmartAssist over low purge pressure risk
    Abiomed has issued a recall of specific Impella CP Sets with SmartAssist after discovering that the units do not meet design specifications. The defect can cause low purge pressure events from the…
    fda medwatch · 4mo agoCRLNegative↗ source
  • Hamilton Medical issues updated use instructions for certain breathing circuit sets after serious recall
    Hamilton Medical has sent a letter to customers on May 18, 2026, advising updated use instructions for specific coaxial breathing circuit sets used with its HAMILTON-C1, HAMILTON T-1 and HAMILTON-M…
    fda medwatch · 4mo agoCRLNegative↗ source
  • Ipsen to acquire Swiss biotech Memo Therapeutics in up to €800 million deal for BK virus drug
    Ipsen announced it will purchase Memo Therapeutics, a Swiss biotech, in a transaction valued at up to about €800 million. The agreement provides Memo investors with €200 million upfront and potent…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Abivax shares jump 40% after Phase 3 data show no excess cancer risk for ulcerative colitis drug
    Abivax reported new safety data from its Phase 3 trial of obefazimod in ulcerative colitis. The data indicated malignancy rates among trial participants were comparable to background rates observed…
    BioPharma Dive · 4mo agoPositive↗ source
  • BridgeBio secures up to $1 billion in preferred equity as United Therapeutics invests $140 million to acquire Thymmune
    BridgeBio Pharma announced that Sixth Street Partners and HealthCare Royalty will provide up to $1 billion in preferred equity to support its upcoming product launches. The financing is structured…
    BioPharma Dive · 4mo agoDealNeutral↗ source
  • Ipsen to buy Kartos Therapeutics for $450M, gaining Phase 3 myelofibrosis drug navtemadlin
    French pharmaceutical company Ipsen announced it will acquire California-based Kartos Therapeutics, paying $450 million upfront. The acquisition gives Ipsen control of navtemadlin, an MDM2 inhibito…
    BioPharma Dive · 4mo agoDealNeutral↗ source
  • FDA approves Viridian's Lumvoa, positioning it against Amgen's Tepezza in thyroid eye disease
    The Food and Drug Administration has granted approval for Viridian Therapeutics' drug Lumvoa to treat thyroid eye disease, an autoimmune condition that can cause eye pain, bulging and vision proble…
    BioPharma Dive · 4mo agoApprovalPositive↗ source
  • Beeline Medicines raises $126.3M, bringing total Series A funding to $426.3M for immune‑drug development
    Beeline Medicines announced an additional $126.3 million in Series A financing, pushing the total raised to $426.3 million. The capital boost was disclosed on Tuesday and follows an earlier spring…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • FDA gene and cell therapy review office loses acting director Vijay Kumar
    Vijay Kumar has announced he will step down from his role as acting director of the Office of Gene and Cell Therapy Reviews within the FDA's Center for Biologics Evaluation and Research. Karim Mik…
    BioPharma Dive · 4mo agoRegulatoryNeutral↗ source
  • Biotech firms raise record funds in 2026, with $2.1 bn round for Isomorphic Labs
    After a few slow years, the biotech financing landscape is showing signs of recovery, though investors remain cautious about where they place capital. A recent PharmaVoice reader poll found that 2…
    BioPharma Dive · 4mo agoDealNeutral↗ source
  • Biotech sector eyes key clinical trial readouts in H2 2026 across cancer, Alzheimer’s and autoimmune diseases
    The first half of 2026 saw a surge in biotech activity, with record‑high deal flow, several large IPOs and a regulatory environment that appears to be stabilising after a period of uncertainty. An…
    BioPharma Dive · 4mo agoNeutral↗ source
  • Theravance, after clinical setbacks, agrees to $929M buyout
    The acquisition by royalty management company Zymeworks follows a "strategic review" triggered by the failure of a drug for a type of low blood pressure.
    BioPharma Dive · 4mo agoDealNeutral↗ source
  • European regulators give second chance approval to Acadia’s Daybu for Rett syndrome
    European Medicines Agency's CHMP has reversed its earlier negative vote and now recommends marketing authorization for Acadia Pharmaceuticals' drug Daybu (trofinetide) for Rett syndrome. The posit…
    BioPharma Dive · 4mo agoApprovalPositive↗ source
  • FDA accepts resubmission of Replimune’s RP1 cancer therapy, decision due Aug. 2; Merck KGaA announces $11 B life-sciences spend
    The U.S. Food and Drug Administration has accepted Replimune's resubmitted application for its cancer drug RP1, with a final decision slated for August 2 and an advisory committee meeting planned f…
    BioPharma Dive · 4mo agoRegulatoryNeutral↗ source
  • US biotech faces regulatory push as China licensing deals spark security concerns
    A surge in licensing agreements between Chinese pharmaceutical firms and U.S. biotech companies has been noted, with nearly 100 deals announced since early 2025, prompting worry among investors and…
    BioPharma Dive · 4mo agoRegulatoryNegative↗ source
  • Alkermes CEO targets orexin market after strong narcolepsy pill data
    Alkermes' incoming chief executive outlined a strategy to compete with larger rivals in the emerging orexin drug class. Recent mid-June trial results showed the experimental oral compound alixorex…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
  • FDA advisory panel backs Moderna's experimental flu vaccine in adults 50-64, supports accelerated review for 65+
    The FDA's advisory committee voted unanimously to recommend Moderna's mRNA-1010 flu vaccine for adults aged 50 to 64, and also found it beneficial for those 65 and older. The 9-0 vote allows Moder…
    BioPharma Dive · 4mo agoRegulatoryPositive↗ source
  • cAMPfield Therapeutics raises $180 million to develop oral IBD drug prifemilast
    cAMPfield Therapeutics, a California biotech, announced a $180 million Series A financing to advance its oral anti‑inflammatory candidate for inflammatory bowel disease. The investigational drug,…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Biogen to acquire RayThera in up to $1 billion deal for immunology pipeline
    Biogen announced it will acquire RayThera, a startup founded in 2023, in a deal valued at up to $1 billion. The acquisition gives Biogen access to RayThera’s immunology pipeline, which includes th…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Pfizer CFO Dave Denton to leave; Denali Therapeutics sells $195 million FDA priority review voucher
    Pfizer announced that its chief financial officer Dave Denton will depart on Aug. 15 to take a role outside the pharmaceutical sector. He has been CFO since May 2022. In the interim, finance chief…
    BioPharma Dive · 4mo agoDealNeutral↗ source
  • Cardiovascular biotech Kardigan raises $400M in IPO, fourth 2026 $400M+ offering
    Kardigan, a cardiovascular drug startup, priced a $400 million initial public offering on Wednesday, adding to a recent surge in large biotech offerings. The company becomes the fourth biotech in…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • UniQure plans to file Huntington’s disease gene therapy with FDA after leadership shift eases data requirements
    UniQure, a Dutch biotech, announced it will seek FDA approval for its gene therapy targeting Huntington’s disease later this summer. The company said FDA staff indicated that three years of data f…
    BioPharma Dive · 4mo agoRegulatoryNeutral↗ source