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2,352 stories matching this filter · ← front page

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  • Bristol Myers shows modest revenue rise, Biogen beats forecasts, Regeneron outlook remains uncertain
    BioPharma Dive highlighted the latest quarterly earnings from three major biotech firms, noting how investors are interpreting the results. Bristol Myers Squibb reported $11.5 billion in revenue f…
    BioPharma Dive · 4mo agoEarningsNeutral↗ source
  • FDA approves Arvinas' PROTAC drug Veppanu for specific metastatic breast cancer
    U.S. regulators have granted approval for Veppanu, a protein-degrading therapy developed by biotech firm Arvinas, to treat a defined group of patients with metastatic, estrogen-receptor-positive, H…
    BioPharma Dive · 4mo agoApprovalPositive↗ source
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fda recalls71
fda medwatch61
fda press38
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Psychiatry & CNS881
Ophthalmology516
Pain495
Endocrinology & Metabolism487
Infectious Disease455
  • Summit Therapeutics' ivonescimab misses interim goal, shares tumble 27% as trial setback raises doubts
    Summit Therapeutics reported that its experimental immunotherapy ivonescimab failed to achieve statistical significance at an interim analysis of the late-stage HARMONi-3 trial in frontline non‑sma…
    BioPharma Dive · 4mo agoNegative readoutNegative↗ source
  • Moderna reports Q1 revenue surge driven by international COVID vaccine sales despite larger net loss
    Moderna posted first‑quarter revenue of $389 million, more than triple the same period a year earlier, primarily from overseas COVID‑19 vaccine sales. The company recorded a net loss of $1.3 billi…
    BioPharma Dive · 4mo agoEarningsNeutral↗ source
  • Axsome receives FDA nod for Alzheimer’s agitation treatment
    Axsome announced that the U.S. Food and Drug Administration granted it a nod for a therapy aimed at agitation associated with Alzheimer’s disease, according to the STAT+ report. The decision marks…
    STAT · 4mo agoApprovalPositive↗ source
  • FDA proposes removing obesity and diabetes drug ingredients from compounding substances list
    The U.S. Food and Drug Administration has issued a proposal to remove the active ingredients of widely used obesity and diabetes medicines from the list of substances that can be compounded. The ch…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • FDA drops Casey Means as surgeon general nominee, naming Fox News radiologist Nicole Saphier instead
    FDA withdrew the nomination of Casey Means for surgeon general and appointed Nicole Saphier, a radiologist and Fox News commentator. The switch underscores the administration’s limited sway in the…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Ailux appoints former AstraZeneca executive Maria Belvisi as chief scientific officer
    Ailux announced the hiring of Maria Belvisi as its new chief scientific officer. Belvisi comes from AstraZeneca where she served as senior vice president of research and development for respirator…
    STAT · 4mo agoPositive↗ source
  • Opinion: America is worrying about fertility again. But it’s not really about families
    Where the state once worried about too many births, it now worries about too few.
    STAT · 4mo ago↗ source
  • STAT+: Her daughter Mila got a bespoke medicine. Now she’s starting a new biotech to make more
    Efforts to make customized medicines at scale have hit commercial and regulatory roadblocks. Julia Vintarello is trying again.
    STAT · 4mo ago↗ source
  • ‘Forever chemicals’ in baby formula? Scientists unpack FDA results
    FDA review confirmed overall safety of 16 brands of baby formula. In a STAT Q&A, experts unpack what low-level PFAS findings mean to worried moms.
    STAT · 4mo ago↗ source
  • Opinion: The psychedelic revolution is leaving behind people of color
    Psychedelics’ potential as a form of treatment is virtually unmatched. But their promise faces both scientific uncertainty and thorny political questions.
    STAT · 4mo ago↗ source
  • Two biotechs raise a combined $556M in latest spurt of IPOs
    Seaport Therapeutics and Hemab Therapeutics on Thursday became the latest drugmakers to debut on Wall Street, continuing a stretch of large IPOs this year that collectively raised almost $3.2 billion.
    BioPharma Dive · 4mo ago↗ source
  • STAT+: OxyContin maker Purdue Pharma set to dissolve after judge approves its criminal sentence
    At the hearing, the judge heard from mothers who lost sons to overdose, a teenager born into withdrawal, and people who spent years dealing with addiction treatment.
    STAT · 4mo ago↗ source
  • Remembering J. Craig Venter: a relentless scientist who changed biotech — and was all too easily misunderstood
    J. Craig Venter, the scientist whose relentless ambition helped turn genetics from an artisanal trade into an industrialized information machine, died at 79.
    STAT · 4mo ago↗ source
  • STAT+: Katherine Szarama named acting director of FDA’s vaccines and biologics center
    Katherine Szarama, who joined the FDA last year to serve as Vinay Prasad’s deputy, will now fill his shoes at CBER.
    STAT · 4mo ago↗ source
  • STAT+: In her own words: Surgeon general nominee Nicole Saphier expresses enthusiasm and caution for MAHA
    Examining the past statements and writings of Trump's third surgeon general nominee, Dr. Nicole Saphier, on vaccines, autism, peptides, diet and more.
    STAT · 4mo ago↗ source
  • STAT+: Hair-raising trial results, and Servier’s M&A wishlist
    Why are investors excited about hair loss drugs? Will AI make clinical trials run more smoothly? And more in "The Readout LOUD," STAT's weekly biotech podcast.
    STAT · 4mo ago↗ source
  • STAT+: As artificial intelligence shows off diagnostic chops, scientists reckon with the way forward
    On Thursday, researchers published in Science the results of a study that tested an OpenAI model on diagnostic and clinical reasoning tasks.
    STAT · 4mo ago↗ source
  • Trump drops Casey Means as surgeon general nominee, opts for radiologist Nicole Saphier
    Trump slammed Sen. Bill Cassidy for blocking his surgeon general pick, as he nominated a replacement.
    STAT · 4mo ago↗ source
  • Merck still sees ‘compelling’ outlook for Terns leukemia drug
    Despite updated study data that suggest Terns’ treatment may be less differentiated, company executives claimed Thursday that it still could be an important step forward in care.
    BioPharma Dive · 4mo ago↗ source
  • UniQure, in ‘symbolic’ win, to seek UK approval of Huntington’s gene therapy
    News of the submission, which would be the first for UniQure’s closely watched treatment, comes as the therapy faces an uncertain future in the U.S.
    BioPharma Dive · 4mo ago↗ source
  • STAT+: FDA wants to exclude weight loss drugs from a compounding list
    FDA moves to remove semaglutide, tirzepatide, and liraglutide from its 503B compounding list, saying there's no shortage of GLP-1 drugs from Novo Nordisk and Eli Lilly.
    STAT · 4mo ago↗ source
  • STAT+: Five-way obesity drug is super effective — in mice
    A 'quintuple agonist,' Alector halts it Alzheimer's trial, and more biotech news from The Readout
    STAT · 4mo ago↗ source
  • STAT+: DOJ, Elevance spar over access to top exec in Medicare Advantage fraud case
    Elevance said a top exec would depart, days after the Justice Department asked to depose him.
    STAT · 4mo ago↗ source