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26 stories matching this filter · ← front page

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  • Regeneron halts Phase 1/2a uveitis trial of anti-CD3 antibody after safety event
    Regeneron announced it is voluntarily ending the Phase 1/2a TITAN study of its anti‑CD3 monoclonal antibody, REGN7041, which was being evaluated for non‑infectious posterior uveitis. The decision…
    Fierce Biotech · 2d agoCRLNegative↗ source
  • Former Legend Biotech CEO Ying Huang appointed head of K2 Therapeutics
    K2 Therapeutics announced that Ying Huang, who recently left his role as CEO of Legend Biotech, will now lead the young biotech company. The appointment comes just weeks after Legend announced Huan…
    Fierce Biotech · 6d agoNeutral↗ source
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73
fda recalls44
fda medwatch39
fda press28
885
Psychiatry & CNS707
Ophthalmology416
Pain371
Endocrinology & Metabolism370
Infectious Disease346
  • Medline issues correction for convenience kits containing recalled ICU Medical pain management components
    Medline announced a correction for certain convenience kits that include ICU Medical pain management components containing Huons Bupivacaine Hydrochloride in Dextrose Injection. The FDA classified…
    fda medwatch · 8d agoCRLNegative↗ source
  • FDA issues early alert on non-sterile BD ChloraPrep applicators in Medline convenience kits
    The FDA's Center for Devices and Radiological Health (CDRH) released an early alert about a potential high‑risk issue with certain Medline convenience kits that contain BD ChloraPrep applicators th…
    fda medwatch · 8d agoRegulatoryNeutral↗ source
  • Combination therapy including leronlimab clears HIV in infant macaques, offering new cure hope
    CytoDyn researchers tested leronlimab together with broadly neutralizing antibodies and antiretroviral therapy in a cohort of 55 infant macaques. Only the eight animals that received the full three…
    Fierce Biotech · 8d agoPositive readoutPositive↗ source
  • Roche launches cyclospora PCR tests as lettuce-linked outbreak spreads across 15 US states
    Roche Diagnostics announced the rollout of two new real-time PCR assays that detect the parasite Cyclospora cayetanensis. The launch comes as the CDC and FDA report that the cyclospora outbreak li…
    Fierce Biotech · 12d agoPositive↗ source
  • Vedanta Biosciences secures $60 million to complete Phase 3 trial of C. difficile microbiome therapy
    Vedanta Biosciences, a Cambridge, MA biotech focused on microbiome therapeutics, announced it has raised $60 million in new financing. The capital will be used to advance its lead candidate target…
    Endpoints · 13d agoDealPositive↗ source
  • Fecal microbiome transplant boosts peanut tolerance sixfold in early trial
    Researchers at Boston Children’s Hospital conducted a small open‑label phase 1 trial in which 15 adult participants received oral encapsulated fecal microbiome transplantation to test safety and ef…
    Fierce Biotech · 14d agoPositive readoutPositive↗ source
  • Expedition Therapeutics raises $115M Series B to fund phase 2 COPD trial of DPP1 inhibitor
    Expedition Therapeutics, backed by Sanofi, announced a $115 million Series B financing round. The round was led by General Atlantic with participation from RA Capital, Vivo Capital, and existing i…
    Fierce Biotech · 15d agoDealPositive↗ source
  • American Regent recalls two lots of Adequan canine injection and two lots of Adequan i.m. for horses due to glass fibers
    American Regent Animal Health announced a nationwide recall of specific lots of its Adequan products for dogs and horses. The recall includes two lots of the 100 mg/mL 5 mL multi‑dose canine injec…
    fda medwatch · 17d agoCRLNegative↗ source
  • Moderna delays norovirus vaccine readout, cites insufficient infections
    Moderna announced that its norovirus vaccine trial will not yield efficacy data this season because infection rates were lower than expected. The company said it will open an additional trial coho…
    Endpoints · 19d agoNegative readoutNeutral↗ source
  • Argon Medical issues correction for convenience kits containing lidocaine ampules after FDA safety alert
    Argon Medical has sent a correction notice to customers about certain convenience kits that include lidocaine HCl ampules supplied by Spectra Medical Devices. The FDA has classified this correctio…
    fda medwatch · 21d agoCRLNegative↗ source
  • Merck launches voluntary licensing for investigational monthly HIV PrEP pill ahead of approval
    Merck has signed voluntary licensing agreements to allow generic manufacturers to produce its investigational monthly HIV PrEP pill, alimatravir, before any regulatory submission. The agreements c…
    Fierce Biotech · 26d agoDealPositive↗ source
  • B. Braun pulls spinal anesthesia kits after recall of bupivacaine in dextrose injection
    B. Braun Medical, Inc. has issued a recall of several spinal anesthesia convenience kits that contain Huons bupivacaine hydrochloride in dextrose injection. The recall follows a request from Huons…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Arrow International issues correction for convenience kits containing recalled saline, lidocaine and bupivacaine
    Arrow International, a Teleflex subsidiary, sent a correction notice to customers about certain convenience kits. The kits contain 10 mL saline ampules, lidocaine and bupivacaine. The FDA classifi…
    fda medwatch · 1mo agoCRLNeutral↗ source
  • ‘Substantially better than before’: Why India has golden opportunity to build on innovative R&D wins
    A string of recent wins on the frontiers of novel drug development could mean that a homegrown innovation industry is within reach.
    Fierce Biotech · 1mo agoNeutral↗ source
  • Baxter issues urgent correction for Volara breathing device circuits due to leak risk
    Baxter has sent an Urgent Medical Device Correction notice to customers using its Volara Positive Pressure Breathing System, advising that all patient circuits be corrected before further use. The…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Early Alert: Convenience Kits Issue from Medline
    Certain BD ChloraPrep Applicators in Convenience Kits manufactured by Medline may not be sterile.
    fda medwatch · 1mo ago↗ source
  • Convenience Kit Correction: Windstone Medical Packaging, Inc. Issues Correction for Convenience Kit
    Certain Cardinal Health Webcol Large Alcohol Prep Pads in Custom Convenience Kits manufactured by Aligned Medical Solutions are not sterile.
    fda medwatch · 1mo ago↗ source
  • Ipsen to scoop up Memo Therapeutics and its kidney infection drug
    Ipsen is on an M&A roll. The French drugmaker announced its second deal of the week, saying it would buy Memo Therapeutics and its drug candidate called potravitug for a viral ...
    Endpoints · 1mo ago↗ source
  • Exclusive: Genentech closes infectious disease unit in wave of research layoffs
    Roche's Genentech underwent another round of layoffs this week in its early research and development group, Endpoints News has learned, which included shuttering two research units and the departur…
    Endpoints · 2mo ago↗ source
  • Five Under 5: Top Oncology Videos for the Week of 5/3
    The top 5 OncLive TV videos of the week cover insights in ovarian cancer, classical Hodgkin lymphoma, pancreatic cancer, melanoma, and myelofibrosis.
    onclive · 3mo ago↗ source
  • Sylvester Comprehensive Cancer Center Identifies a Screening Gap to Prevent a Type of Leukemia in the U.S.
    Researchers at Sylvester identified populations in the US where this cancer may be largely preventable by addressing mother‑to‑child transmission of the virus.
    onclive · 3mo ago↗ source
  • Consensus Viewpoints Offer Guidance in Rapidly Evolving Multiple Myeloma Management
    Ajai Chari, MD, outlines key consensus viewpoints and recommendations for multiple myeloma management from Bridging the Gaps 2025.
    onclive · 3mo ago↗ source
  • Fierce Biotech Layoff Tracker 2026: Kolon cuts workforce after ph. 3 fail; Sanofi sheds 229 staffers
    As always, if you know of layoffs occurring at a biotech, please reach out to the Fierce Biotech editorial team.
    Fierce Biotech · 7mo ago↗ source