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779 stories matching this filter · ← front page

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  • Kailera's oral GLP-1 pill shows ~10% weight loss in Chinese Phase 3 trial
    Kailera Therapeutics reported that its oral GLP-1 candidate HRS-7535 achieved about 10% average weight loss over 44 weeks in a Phase 3 study in China. The highest daily dose led to a mean 9.8% red…
    BioPharma Dive · 3mo agoPositive readoutNeutral↗ source
  • Fresenius Kabi issues correction for Ivenix infusion pumps over battery health software bug
    The U.S. Food and Drug Administration has classified a correction for Fresenius Kabi’s Ivenix Large Volume infusion pump as the most serious type of recall. The action does not require removal of t…
    fda medwatch · 3mo agoCRLNegative↗ source
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  • Fresenius Kabi urges removal of dropped Ivenix infusion pumps after safety correction
    Fresenius Kabi has issued a safety notice for its Ivenix large-volume infusion pumps. The FDA classified the issue as a Class I recall, the most serious level, because the touchscreen can become un…
    fda medwatch · 3mo agoCRLNegative↗ source
  • Novartis to buy Myricx Bio for up to $1.5 billion, adding two novel ADCs to its oncology portfolio
    Novartis announced it will acquire Myricx Bio, a UK‑based biotech that develops antibody drug conjugates (ADCs), in a move to broaden its oncology pipeline. The transaction is valued at up to $1.5…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Cancer and immune-focused biotech firms capture over $3.9 billion of H1 2026 venture capital
    BioPharma Dive data show that cancer and immune disease biotech companies accounted for more than 40% of the biotech firms receiving venture funding in the first half of 2026. Of the roughly $9 bi…
    BioPharma Dive · 3mo agoDealNeutral↗ source
  • Gene-editing biotech Scribe Therapeutics files for Nasdaq IPO
    Scribe Therapeutics, a California-based biotechnology startup developing genetic medicines for cardiometabolic disorders, announced plans to go public on the Nasdaq under the ticker SCTX. The comp…
    BioPharma Dive · 3mo agoDealNeutral↗ source
  • Windstone Medical issues correction for non-sterile alcohol prep pads in custom convenience kits
    Windstone Medical Packaging, Inc. has released a correction notice for several custom convenience kits that include Cardinal Health Webcol large alcohol prep pads that were found to be non-sterile.…
    fda medwatch · 3mo agoCRLNegative↗ source
  • 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 · 3mo 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 · 3mo agoPositive readoutPositive↗ source
  • 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 · 3mo 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 · 3mo 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 · 3mo agoCRLNegative↗ source
  • FDA Grants First Gene-Therapy Approval for Children 2+ with Sickle Cell Disease
    The U.S. Food and Drug Administration issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged two years and older who have sickle cell disease with recurrent vaso-oc…
    fda press · 3mo agoApprovalPositive↗ 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 · 3mo 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 · 3mo 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 · 3mo agoDealNeutral↗ source
  • FDA approves Tregzi, first T‑reg cell therapy to lower chronic GVHD risk in blood‑cancer transplants
    The FDA announced approval of Tregzi, a regulatory T‑cell based immunotherapy designed to improve chronic graft‑versus‑host disease‑free survival for adults with blood cancers undergoing allogeneic…
    fda press · 3mo agoApprovalPositive↗ 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo agoNeutral↗ source
  • FDA picks seven firms for PreCheck pilot to boost U.S. drug manufacturing
    The FDA announced on June 29, 2026 that seven companies have been chosen for its PreCheck Pilot Program, an initiative aimed at strengthening U.S. drug manufacturing and supply chain resilience. T…
    fda press · 3mo agoRegulatoryPositive↗ 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 · 3mo agoDealNeutral↗ source