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868 stories matching this filter · ← front page

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  • FDA issues early alert on React Health VOCSN ventilators over connector fault
    The FDA's Center for Devices and Radiological Health has posted an early alert about a potential high‑risk problem with certain VOCSN ventilator units made by Ventec Life Systems, operating as Reac…
    fda medwatch · 1mo agoRegulatoryNeutral↗ source
  • AI-driven biotech Enveda secures $311 million Series E to advance plant-derived drug candidates
    Enveda Biosciences, a Colorado AI drug discovery company, announced a $311 million Series E financing round, one of the larger biotech raises this year. The firm uses artificial intelligence to sc…
    BioPharma Dive · 1mo agoDealPositive↗ source
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Nephrology764
  • FDA issues early alert on Abiomed Impella controller safety issue
    The FDA Center for Devices and Radiological Health (CDRH) has posted an Early Alert about a potential high risk problem with certain Abiomed Impella automated controllers. Abiomed has sent a lette…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • Federal Court Issues Consent Decree Halting Gold Star Distribution's FDA-Regulated Shipments Over Unsanitary Warehouse
    The U.S. District Court for the District of Minnesota entered a consent decree on Sept. 21, 2026 that permanently enjoins Gold Star Distribution, Inc. and its owner Bassam Abu Samrah from distribut…
    fda press · 1mo agoRegulatoryNegative↗ source
  • Amgen's Dazodalibep Shows Positive Results in First Phase 3 Trial for Sjögren’s Syndrome
    Amgen announced that its experimental drug dazodalibep, acquired through the Horizon Therapeutics acquisition, met the primary endpoint in the first of two Phase 3 trials for Sjögren’s syndrome, a…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Celldex shares drop as Phase 3 data for barzolvolimab show efficacy but raise anaphylaxis safety concerns
    Celldex reported Phase 3 results for barzolvolimab in chronic spontaneous urticaria, showing strong efficacy against hives and itching. Two cases of life-threatening anaphylaxis were observed amon…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Alkermes reports early proof-of-concept for orexin-2 drug in ADHD
    Alkermes announced early-stage trial results for ALKS 7290, an orexin‑2 receptor agonist originally being developed for narcolepsy, showing proof of concept in ADHD. The study reported dose‑depend…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Viking Therapeutics reports obesity drug maintains weight loss after dosing switch, shares jump 36%
    Viking Therapeutics said its Phase 2 trial of the dual-acting obesity candidate VK2735 showed participants largely kept the weight they had lost when the dosing schedule changed from a weekly injec…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Trump administration’s MFN drug pricing deals may cut projected Medicare savings by up to 80%
    The White House announced "most-favored-nation" pricing agreements with 26 pharmaceutical companies, saying the contracts would lower drug costs for federal programs. The deals require companies to…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • FDA issues rule to allow non-animal testing methods for drug safety
    FDA issued a direct final rule that updates its regulations to clarify that non-animal methods may be used for safety testing of drugs and biological products before they are tested in humans. The…
    fda press · 1mo agoRegulatoryPositive↗ source
  • Telix to acquire Germany's ITM for $1.65 billion, aiming to dominate radiopharmaceutical market
    Telix, an Australian radiopharmaceutical diagnostics company, announced it will purchase German developer ITM in a cash transaction valued at $1.65 billion upfront. The agreement gives Telix the o…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Novo outlines plan for multiple new drugs to regain market share as shares dip 8%
    At a capital markets day in London, Novo executives presented a roadmap to launch more than five multi-blockbuster drugs by 2030 and target $23 billion in annual sales by 2035, aiming to offset the…
    BioPharma Dive · 1mo agoNegative↗ source
  • Walgreens Specialty Pharmacy highlights holistic support to boost oncology medication adherence
    Advances in oncology are moving care out of the clinic and into patients' homes, with treatments becoming more personalized. This shift means patients often manage complex drug schedules themselves…
    BioPharma Dive · 1mo agoPositive↗ source
  • Healthcare systems lag behind rapid expansion of GLP-1 therapies, raising care and trust challenges
    GLP-1 drugs have demonstrated that pharmacological treatment can effectively reduce obesity, and regulators have now approved them for additional uses such as cardiovascular risk reduction, metabol…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Par Health recalls two lots of dexmedetomidine infusion due to particulate contamination
    Par Health announced a voluntary recall of two lots of its dexmedetomidine HCl in 0.9% sodium chloride injection, which is used for intravenous sedation. The recall was initiated after testing ide…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Otsuka ICU Medical recalls one lot of 0.9% Sodium Chloride injection after possible potassium chloride mix-up
    Otsuka ICU Medical LLC announced a voluntary recall of a single lot of its 0.9% Sodium Chloride Injection, USP, 100 mL. The recall was triggered after a customer complaint revealed that the overwr…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • CooperSurgical issues recall of INCA infant nasal CPAP sets over loose connection risk
    CooperSurgical has announced a recall of its INCA infant nasal CPAP complete and replacement sets. The recall is due to a potential loose connection between the flexible tubing and the nasal cannu…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Compass eyes J&J’s Spravato playbook for upcoming psychedelic drug COMP360 launch
    Compass executives told BioPharma Dive that, if the FDA approves their treatment, they plan to follow the commercial strategy Johnson & Johnson used for its ketamine spray Spravato. When Spravato…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Beacon eye gene therapy hits mark in late-stage study
    Beacon claimed the findings represent the first time a treatment for X-linked retinitis pigmentosa, a rare and potentially blinding condition, met its main goal in a pivotal trial.
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • AVID Medical issues correction for convenience kits containing recalled Huons sodium chloride ampules
    AVID Medical has released a correction notice for certain convenience kits that include sodium chloride ampules from Huons Co., which are subject to a recall. The FDA has classified this recall as…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • Xenon shares tumble up to 30% after pausing depression trial over neuropsychiatric events
    Xenon Pharmaceuticals announced it is pausing enrollment in its depression trial for the drug azetukalner after neuropsychiatric adverse events emerged that were not observed in earlier testing. A…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Electra Therapeutics raises $350M in biotech IPO, fueling rare disease drug development
    Electra Therapeutics completed a $350 million initial public offering, becoming the 21st biotechnology company to go public in 2026. The strong demand for its shares highlights continued investor a…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • GSK adds two China cancer-therapy licensing deals, keeping pace with industry partnership surge
    BioPharma Dive's new visualization series recapped recent activity, spotlighting GSK's licensing agreements in China and the market response. Since the start of 2025, GSK has signed five deals wit…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Ultragenyx prices Sanfilippo gene therapy at $4 million as it gains a second FDA approval; Bristol Myers halts Orum cancer drug
    The FDA approved Fayuvi, the first gene therapy for Sanfilippo syndrome Type A, with a list price of $3.95 million. This marks Ultragenyx's second gene‑therapy approval since August, earning sella…
    BioPharma Dive · 1mo agoApprovalNeutral↗ source
  • Spectra Medical recalls Sodium Chloride Flush ampules due to serious safety risk
    Spectra Medical Devices has issued a recall of its Sodium Chloride Injection 0.9% USP 10 mL flush ampules that were manufactured by Huons Co., Ltd. The FDA classified the recall as the most serious…
    fda medwatch · 1mo agoCRLNegative↗ source