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15 stories matching this filter · ← front page

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STAT1024Endpoints778BioPharma Dive297BioSpace214Fierce Biotech203onclive165raps74globenewswire health
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allOncology6027Rare Disease1434Cardiology1089Hematology1024Immunology1000Vaccines902Pulmonology
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 1d agoLayoffsNegative↗ source
  • FDA nod is just the first hurdle for Moderna’s potential blockbuster flu vax
    Strain selection timing and mRNA skepticism could limit the impact of Moderna’s game-changing mRNA flu shot.
    BioPharma Dive · 3d agoApprovalPositive↗ source
73
fda recalls47
fda medwatch37
fda press28
899
Psychiatry & CNS712
Ophthalmology421
Endocrinology & Metabolism380
Pain373
Infectious Disease354
  • How AI-enabled Software as Medical Devices are Reshaping Regulatory Routes and Medicine
    As AI-enabled Software as Medical Devices become more prevalent, regulatory agencies are responding with new guidelines and AI-specific authorisation routes. This article looks at current trends, s…
    BioSpace · 3d agoRegulatoryNeutral↗ source
  • Revolution Medicines sees strong demand for pancreatic cancer drug daraxonrasib under compassionate use
    Revolution Medicines reports that more than 2,000 patients have received its pancreatic cancer candidate daraxonrasib through a compassionate use program. The company says the drug has been distri…
    BioPharma Dive · 13d agoPositive↗ source
  • FDA approves Moderna's first mRNA flu vaccine for adults 50 and older
    The Food and Drug Administration has granted approval to Moderna's mRNA flu vaccine, called mFlusiva and previously known as mRNA-1010, making it the first preventive flu shot built on messenger RN…
    BioPharma Dive · 14d agoApprovalPositive↗ source
  • Moderna's mRNA flu vaccine mFLUVISA receives FDA approval after earlier filing refusal
    The U.S. Food and Drug Administration initially issued a refusal-to-file letter to Moderna's flu vaccine in February, but a few days later reversed that decision and accepted a revised submission f…
    BioSpace · 14d agoApprovalPositive↗ source
  • Eli Lilly to buy psychedelics biotech AtaiBeckley for $2.8 billion, adding late-stage depression drug
    Eli Lilly announced it will acquire New York‑based biotech AtaiBeckley in a transaction valued at about $2.8 billion. The agreement sets the purchase price at $6.75 per share, a 26 % premium to At…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Q32 Bio’s alopecia drug bempikibart meets Phase 2 goal, driving shares up 80%
    Q32 Bio reported that its experimental alopecia areata therapy, bempikibart, achieved the primary endpoint in the second part of a Phase 2 trial. Two‑fifths of participants grew enough hair to cove…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Abivax shares surge as worries subside over immune drug’s cancer risk
    According to Abivax, fresh data suggest malignancy rates in its trials were no higher than "background" ones for people with ulcerative colitis, clearing a key safety concern.
    BioPharma Dive · 1mo ago↗ source
  • 10 clinical trials to watch in the second half of 2026
    The biotechnology sector’s upswing accelerated in the first half. Positive results from anticipated trials in lung cancer, Alzheimer’s and multiple autoimmune conditions could add to the momentum.
    BioPharma Dive · 1mo ago↗ source
  • Moderna flu vaccine wins unanimous support from FDA panel
    The endorsement of an advisory committee positions Moderna to complete a dramatic turnaround for a shot the FDA declined to review earlier this year.
    BioPharma Dive · 2mo ago↗ source
  • Lilly buys non-opioid pain drugmaker 4E
    It’s the latest in a string of deals for Lilly, which has sunk more than $18 billion into acquisitions over the past few years.
    BioPharma Dive · 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