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12 stories matching this filter · ← front page

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  • FDA rejects Osteal Therapeutics' combo therapy for joint-implant infections
    The U.S. Food and Drug Administration rejected Osteal Therapeutics' lead combination therapy late last month. The agency cited concerns that prevented approval of the product intended to treat infe…
    Endpoints · 4d agoRegulatoryNegative↗ source
  • FDA grants accelerated approval to Tudriqev viral therapy for PD-1-refractory advanced melanoma
    The U.S. Food and Drug Administration has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically engineered oncolytic viral therapy for patients with advanced, tre…
    fda press · 18d agoApprovalPositive↗ source
73
fda recalls50
fda medwatch45
fda press28
923
Psychiatry & CNS741
Ophthalmology437
Pain414
Endocrinology & Metabolism395
Infectious Disease373
  • 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 · 18d agoDealPositive↗ 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 · 24d agoNegative readoutNeutral↗ source
  • Ipsen to acquire Memo Therapeutics and its kidney infection candidate
    French drugmaker Ipsen announced a new acquisition, agreeing to buy Memo Therapeutics along with its experimental kidney infection drug. This marks Ipsen's second transaction announced within a wee…
    Endpoints · 1mo agoDealPositive↗ source
  • FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children
    The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an in…
    fda press · 2mo ago↗ source
  • FDA Issues Emergency Use Authorization for Generic Over-the-Counter Drug to Treat New World Screwworm in Dogs and Cats
    FDA today issued an Emergency Use Authorization (EUA) for generic Nitenpyram Tablets (nitenpyram) for the treatment of New World screwworm (NWS) infestations (myiasis) in dogs, puppies, cats, and k…
    fda press · 2mo 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
  • FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
    Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarr…
    fda press · 3mo 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