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205 stories matching this filter · ← front page

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  • Pfizer halts Phase 2 trial of PF-06835375 in primary immune thrombocytopenia
    Pfizer announced that it is stopping its Phase 2 study of the experimental program PF-06835375, which was being evaluated in patients with primary immune thrombocytopenia, a rare autoimmune blood d…
    Endpoints · 4h agoNegative readoutNegative↗ source
  • Pharma pours billions into bispecifics, ADCs and cell therapies despite limited clinical proof
    The article notes that emerging drug formats such as bispecific antibodies, antibody‑drug conjugates and cell therapies have yet to demonstrate clear clinical success, yet pharmaceutical firms cont…
    BioPharma Dive · 6h agoNeutral↗ source
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Nephrology633
  • Cardinal Health issues updated instructions for Presource kits containing recalled BD Alaris infusion sets
    The FDA CDRH issued an Early Alert to inform the public of a potentially high‑risk device issue involving Cardinal Health Presource kits that may contain BD Alaris Pump Infusion Sets linked to a re…
    fda medwatch · 14h agoRegulatoryNegative↗ source
  • Nova Biomedical pulls Gen 2.0 StatStrip hospital glucose meters over patient ID software flaw
    Nova Biomedical has issued a recall of its StatStrip Glucose Hospital Meter System Gen 2.0 model after discovering a software issue that could assign glucose results to the wrong patient. The FDA…
    fda medwatch · 14h agoCRLNegative↗ source
  • Merck KGaA to acquire Silence Therapeutics for $1.3 billion, adding Phase-2 RNAi drug for polycythemia vera
    Merck KGaA announced it will purchase UK‑based Silence Therapeutics for about $1.3 billion, paying $20 in cash per share, representing a 130 % premium. The deal gives Merck control of an RNA‑inter…
    BioPharma Dive · 1d agoDealPositive↗ source
  • Disc Medicine reports positive Phase 3 results for bitopertin in erythropoietic porphyria
    Disc Medicine announced that its experimental therapy bitopertin achieved its primary and secondary goals in a Phase 3 trial for erythropoietic porphyria, a rare condition that makes patients extre…
    BioPharma Dive · 1d agoPositive readoutPositive↗ source
  • City Therapeutics raises $200 million in IPO to fund next-gen RNAi programs
    City Therapeutics, a biotech focused on RNA interference, completed a $200 million initial public offering, selling about 11.1 million shares at $18 each. The proceeds will back three drug candida…
    BioPharma Dive · 4d agoDealPositive↗ source
  • Belgian startup Armed Cell Therapeutics acquires Galapagos-derived CAR-T assets for €8 million upfront
    Armed Cell Therapeutics, a new Belgian biotech chaired by former Galapagos CEO Paul Stoffels, has taken ownership of several cell therapy programs previously held by Lakefront Biotherapeutics. The…
    BioPharma Dive · 5d agoDealPositive↗ source
  • FDA issues early alert on Edwards Lifesciences transcatheter mitral valve delivery system after balloon burst reports
    The FDA's Center for Devices and Radiological Health issued an early alert about a potential high‑risk issue with certain Edwards Lifesciences delivery systems used in the SAPIEN M3 transcatheter m…
    fda medwatch · 5d agoRegulatoryNegative↗ source
  • FDA expands Anktiva use for BCG-unresponsive high-grade papillary bladder cancer
    The U.S. Food and Drug Administration has broadened the approved use of Anktiva, a therapy given with Bacillus Calmette-Guérin, to treat adults with high-grade papillary-only bladder cancer that ha…
    fda press · 6d agoApprovalPositive↗ source
  • Arrowhead’s experimental RNAi drug ARO-MAPT cuts tau protein by 73% in early human trial
    Arrowhead Pharmaceuticals said its experimental RNA interference therapy, ARO-MAPT, lowered the Alzheimer’s‑linked tau protein in a first‑in‑human study of healthy volunteers. The early‑stage tria…
    BioPharma Dive · 6d agoPositive readoutPositive↗ source
  • Johnson & Johnson shares drop 6% after earnings meet forecasts but show weak medical device outlook
    Johnson & Johnson reported third‑quarter results that met Wall Street expectations and raised its 2026 financial guidance, yet the stock fell about 6% on the day. Analysts highlighted an underwhel…
    BioPharma Dive · 6d agoEarningsNegative↗ source
  • BD and CareFusion recall Alaris Pump infusion sets due to serious performance risks
    The FDA has classified the recall of BD Alaris Pump infusion sets as the most serious type, warning that continued use could cause serious injury or death. BD and its subsidiary CareFusion sent an…
    fda medwatch · 6d agoCRLNegative↗ source
  • FDA review flags limited efficacy of Revolution's pancreatic cancer drug Rasonque, shares drop 6%
    Shares of Revolution Medicines fell about 6% after the Food and Drug Administration released review documents that suggest its pancreatic cancer therapy Rasonque may not work as well in all patient…
    BioPharma Dive · 11d agoRegulatoryNegative↗ source
  • Dutch court blocks Merck's subcutaneous Keytruda sales in eight European countries after Halozyme patent win
    A Netherlands court issued an injunction that stops Merck from marketing its subcutaneous formulation of Keytruda, known as Keytruda Qlex, in eight European markets. The ruling follows a patent in…
    BioPharma Dive · 13d agoRegulatoryNeutral↗ source
  • AbbVie/Genmab’s Epkinly halves progression risk in frontline DLBCL trial
    A Phase 3 study of the bispecific antibody Epkinly combined with standard chemotherapy showed nearly a 50% reduction in the risk of disease progression or death compared with chemotherapy alone in…
    BioPharma Dive · 14d agoPositive readoutPositive↗ source
  • Key Biopharma Conferences to Watch in 2027 Highlight Industry Trends
    The article lists major medical meetings slated for 2027 that serve as platforms for companies to present clinical data and network. Highlights include the J.P. Morgan Healthcare Conference in ear…
    BioPharma Dive · 14d agoNeutral↗ source
  • Nobel Prize honors optogenetics pioneers; Roche licenses Alector’s Parkinson’s enzyme therapy
    The Nobel Committee awarded this year’s Physiology or Medicine prize to three scientists whose work created the field of optogenetics. Their discoveries of a light‑sensing protein in algae and its…
    BioPharma Dive · 15d agoDealPositive↗ source
  • ICU Medical updates IV tubing set instructions after reports of black specks in drip chambers
    ICU Medical has issued a final update letter recommending revised use instructions for several of its IV tubing sets after reports of black specks and particulate matter in the drip chambers. The…
    fda medwatch · 15d agoRegulatoryNeutral↗ source
  • Novartis pays $575 million upfront for access to Chinese biotech Abogen’s RNA platform and option on ABO-2203
    Novartis announced a deal with China‑based Abogen Biosciences that could be worth up to $7.8 billion. The agreement includes an upfront payment of $575 million. Under the deal, Abogen will provide…
    BioPharma Dive · 18d agoDealPositive↗ source
  • FDA approves first pediatric heart valve that expands as children grow
    The U.S. Food and Drug Administration has approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for children with congenital pulmonary valve disease. The device is…
    fda press · 18d agoApprovalPositive↗ source
  • Bristol Myers revises Phase 3 fibrosis trial after liver safety events, including a death
    Bristol Myers Squibb announced a change to its late-stage Phase 3 "Aloft" trial of the experimental pulmonary fibrosis drug admilparant. The amendment adds closer monitoring for liver-related adve…
    BioPharma Dive · 20d agoNegative readoutNegative↗ source
  • FDA approves Emcitate for peripheral thyrotoxicosis in patients with MCT8 deficiency
    The U.S. Food and Drug Administration announced approval of Emcitate (tiratricol) tablets formulated for oral suspension to treat peripheral thyrotoxicosis in patients with MCT8 deficiency, also ca…
    fda press · 21d agoApprovalPositive↗ source
  • Kodiak Sciences' Phase 3 eye drug data beats Regeneron’s Eylea, shares double
    Kodiak Sciences reported that its two experimental treatments for macular degeneration met the primary endpoints in a Phase 3 trial that directly compared them with Regeneron’s Eylea. The data show…
    BioPharma Dive · 22d agoPositive readoutPositive↗ source
  • White House seeks data on U.S. manufacturing of 86 essential medicines
    The White House Office of Management and Budget has launched a review of domestic production for a list of 86 medicines deemed essential. The request asks manufacturers to provide information on w…
    Endpoints · 22d agoRegulatoryNeutral↗ source