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930 stories matching this filter · ← front page

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  • Roche reports updated eye drug data and FDA filing acceptance, targets July 2027 decision
    Roche Genentech has presented new data from its eye disease trials, a year after a mixed Phase 3 readout, and noted that the FDA has accepted its filing for vamikibart with a decision slated for Ju…
    Fierce Biotech · 8d agoRegulatoryPositive↗ source
  • Tortugas Neuroscience's obuprazine shows significant improvement in phase 2b schizophrenia trial in China
    Tortugas Neuroscience, a biotech founded by former Sage Therapeutics staff with $106 million in funding, reported positive data from a phase 2b study of its schizophrenia candidate obuprazine, lice…
    Fierce Biotech · 8d agoPositive readoutPositive↗ source
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Ophthalmology841
Endocrinology & Metabolism684
Pain650
Nephrology633
  • FDA approves new treatments for persistent herpes and schizophrenia; Steris to acquire Xodus Medical for $2.1 billion
    The U.S. Food and Drug Administration has granted approvals for two new drugs, one targeting persistent herpes infections and another for the treatment of schizophrenia. The herpes indication addr…
    raps · 8d agoApprovalPositive↗ source
  • FDA finalizes guidance aligning biosimilar post-approval manufacturing changes with global standards
    The U.S. Food and Drug Administration has issued its final guidance on how biosimilar manufacturers can implement post-approval changes to their production processes. The new recommendations bring…
    raps · 8d agoRegulatoryNeutral↗ source
  • Merck’s deeper dive into efficacy, safety of $1.3B eye disease drug raises fears of ‘limited’ potential
    Merck & Co. has poured out its Brunello data, revealing a mix of undifferentiated efficacy and concerning safety that led analysts to predict “limited competitive potential” in diabetic macular ede…
    Fierce Biotech · 8d agoRegulatoryNeutral↗ source
  • Japan's PMDA Issues Guidance to Safeguard Participants in Generic Bioequivalence Trials
    The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has released new guidance aimed at protecting healthy adult volunteers who take part in generic bioequivalence studies. The document…
    raps · 8d agoRegulatoryNeutral↗ source
  • Europe’s share of clinical trials falls 13.5% as Asia’s research footprint expands
    The latest data show a 13.5% drop in the number of clinical trials authorized in the EU and EEA compared with pre-pandemic levels. At the same time, Asian countries have increased their share of g…
    raps · 8d agoNeutral↗ source
  • Parkinson’s-focused Aspen and bispecific biotech Bambusa plan IPOs
    Parkinson’s disease cell therapy-focused Aspen Neuroscience and bispecific biotech Bambusa Therapeutics are the latest drug developers to eye up a public listing.
    Fierce Biotech · 10d ago↗ source
  • Lilly-backed TRex Bio raises $117M in IPO as hypertension biotech Retension secures $45M listing
    TRex Bio, a biotech backed by Eli Lilly, completed its initial public offering, generating $116.7 million in gross proceeds. The company sold 8.3 million shares at $14 each, landing at the lower en…
    Fierce Biotech · 11d agoDealPositive↗ source
  • GSK partners with Chai Discovery to use AI protein-folding models after successful wet-lab tests
    GSK has entered a collaboration with Chai Discovery, a biotech firm that offers AI‑driven protein folding and design tools. The agreement gives GSK access to Chai's models, which were reported to…
    Fierce Biotech · 11d agoDealPositive↗ source
  • Pfizer signs $500M deal with Enodia to develop Sec61 protein degraders
    Pfizer has entered a licensing and research collaboration with Enodia Therapeutics, valued at up to $500 million, to discover and develop inhibitors of the Sec61 protein‑translocation channel. The…
    Fierce Biotech · 11d agoDealNeutral↗ source
  • Fierce Biotech outlines criteria for its 2026 Fierce 15 list, spotlighting top innovators
    The Fierce Biotech editorial team released its 2026 Fierce 15 list and discussed the selection process on a recent episode of "The Top Line" podcast. More than 150 high‑quality entries were review…
    Fierce Biotech · 11d agoPositive↗ source
  • Nobel-winning optogenetics sees growing biotech interest
    Karl Deisseroth, a Stanford psychiatrist and bioengineer, learned he had shared the 2026 Nobel Prize in Physiology or Medicine for pioneering optogenetics, a method that makes neurons responsive to…
    Fierce Biotech · 11d agoPositive↗ source
  • FDA week: HHS launches vaccine injury study, midterms may reshape oversight committees, and patent thickets threaten generics
    The Department of Health and Human Services announced a new agency‑wide effort to examine and address injuries that may be linked to vaccines. The initiative will coordinate research across FDA and…
    raps · 11d agoRegulatoryNeutral↗ source
  • Study finds rising patent thickets may slow generic drug competition
    A recent special communication in JAMA reports that the number of patents linked to FDA‑approved small‑molecule drugs has risen over the past 15 years. The increase is driven largely by non‑primary…
    raps · 11d agoNeutral↗ source
  • BD appoints Ferass Abuzaina as Worldwide President of Surgery
    Becton, Dickinson and Company announced that Ferass Abuzaina will serve as the new Worldwide President of its Surgery business unit, effective immediately. He will oversee the global strategy, oper…
    Fierce Biotech · 11d agoPositive↗ source
  • FDA issues early alert on Philips Lumify ultrasound system software and connection problems
    The FDA’s Center for Devices and Radiological Health has released an Early Alert about a potential high‑risk issue with Philips Lumify diagnostic ultrasound devices. The problem involves either a s…
    fda medwatch · 11d agoRegulatoryNegative↗ source
  • Oliva LLC recalls 250 units of Riad's Oliva to Go dips over undeclared sesame
    Oliva LLC of Bethlehem, Connecticut announced a voluntary recall of about 250 units of its Riad's Oliva to Go line, including Baba Ghanouj, Spicy Baba Ghanouj and Hummus. The recall was triggered…
    fda recalls · 10d agoCRLNegative↗ source
  • Krasnyi Oktyabr Recalls Starfish Seafood Trio Over Listeria Risk
    Krasnyi Oktyabr Inc. of Brooklyn, New York announced a voluntary recall of its Starfish Seafood Trio, which includes cold smoked salmon, halibut and trout packaged in 8‑oz vacuum‑sealed packs. The…
    fda recalls · 10d agoCRLNegative↗ source
  • Hengrui has become the go-to source of China biopharma innovation. What’s its secret?
    Amid the Chinese biotech licensing boom, Hengrui Pharmaceuticals stands out from the crowd. The Jiangsu-based biopharma landed one of the largest licensing deals ever by a Chinese company courtesy…
    Fierce Biotech · 11d ago↗ source
  • Krasnyi Oktyabr Inc. Recalls Starfish Seafood Premium Cold Smoked Norwegian Salmon Sliced (227g/8oz) Because of Possible Health Risk
    Krasnyi Oktyabr Inc. of Brooklyn, New York, is voluntarily recalling STARFISH SEAFOOD PREMIUM COLD SMOKED NORWEGIAN SALMON SLICED (227g/8oz) packages, because the product has the potential to be co…
    fda recalls · 11d ago↗ source
  • Endeavor BioMedicines reports positive phase 2b results for Hedgehog inhibitor taladegib in IPF
    Endeavor BioMedicines announced that its Hedgehog pathway inhibitor, taladegib, produced encouraging results in a phase 2b study of patients with idiopathic pulmonary fibrosis (IPF). The trial, nam…
    Fierce Biotech · 12d agoPositive readoutPositive↗ source
  • Par Health recalls two lots of Brevital Sodium injection over cellulose particles
    Par Health announced a voluntary recall of two lots of its Brevital® Sodium 500 mg/vial for injection after detecting particulate matter identified as cellulose. The recall is being executed at th…
    fda recalls · 11d agoRegulatoryNegative↗ source
  • Iambic Therapeutics targets $135M IPO to fund clinical trials of HER2 and KIF18A cancer drugs
    Iambic Therapeutics, a San Diego AI‑driven biotech, filed to raise $135 million in net proceeds through an initial public offering. The company plans to sell 9.4 million shares at $15 to $17 each,…
    Fierce Biotech · 12d agoDealNeutral↗ source
  • Ono Pharmaceutical pays $80 million for Asian rights to Biohaven IgG degrader trio, including phase-3 Graves disease candidate
    Japan's Ono Pharmaceutical has agreed to pay $80 million upfront for the rights to three Biohaven IgG degrader programs in Japan, South Korea, Taiwan and ASEAN markets. The agreement also includes…
    Fierce Biotech · 12d agoDealNeutral↗ source