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3,209 stories matching this filter · ← front page

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  • 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
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  • 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
  • Seaport Therapeutics jumps over 20% on Nasdaq debut as former Karuna team outlines CNS research plans
    Seaport Therapeutics began trading on Nasdaq on May 1, 2026, ringing the opening bell. Its shares surged more than 20% on the first day. The company’s leadership, including the CEO and CSO, highli…
    Endpoints · 4mo agoPositive↗ source
  • Samsung Biologics workers launch five-day strike over wage dispute
    On May 1, 2026 union workers at Samsung Biologics began a five-day strike after a rally in April. The walkout is over wage negotiations, with about 95% of the company's union members voting in fav…
    Endpoints · 4mo agoNegative↗ source
  • Cue Biopharma names Shao‑Lee Lin CEO and licenses new allergy asset from Taiwan and China
    Cue Biopharma announced a reboot, bringing in biotech veteran Shao‑Lee Lin as its new chief executive. Lin, founder of Acelyrin, will lead the Boston‑based company as it expands its pipeline. The…
    Endpoints · 4mo agoDealPositive↗ 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
  • Premium subscribers invited to exclusive post-hoc Q1 earnings recap live event
    A live, post‑hoc session will be held for premium subscribers that reviews first‑quarter earnings across the pharmaceutical sector, with a particular focus on the deal activity reported in the call…
    Endpoints · 4mo agoNeutral↗ source
  • Summit slips on ivonescimab's apparent interim miss in sign of investor frustration
    Summit Therapeutics’ stock price {$SMMT} tumbled nearly 20% after the closing bell Thursday afternoon, following an apparent statistical miss in part of a Phase 3 trial for its cancer drug ivonesci…
    Endpoints · 4mo ago↗ source
  • Amgen files update to Tavneos label as FDA escalates push to withdraw
    Amgen has taken steps to update its Tavneos label amid an ongoing battle with the FDA. The company filed a supplement on Wednesday that would add more information to the warning ...
    Endpoints · 4mo ago↗ source
  • Seaport, Hemab price IPOs, while Avalyn soars in Nasdaq debut
    A trio of biotechs priced their IPOs on Thursday into Friday morning, setting the stage for their public trading debuts with more than $850 million combined. Seaport Therapeutics, Hemab Therapeutic…
    Endpoints · 4mo ago↗ source
  • J&J axes pair of CAR-T therapies for lymphoma, citing evolving market
    Johnson & Johnson is scrapping two CAR-T cell programs for B cell lymphoma amid a wave of approvals in recent years for cell therapies and antibody-based drugs addressing the disease. The drugmaker
    Endpoints · 4mo ago↗ source
  • Boehringer appoints pharma veteran for corporate affairs post; BlueRock CSO heads for the exit
    → Boehringer Ingelheim has brought in Christie Bloomquist as SVP, corporate affairs, US human pharma, and she’ll be president of the Boehringer Cares Foundation. Peer Review informed you about her…
    Endpoints · 4mo ago↗ 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
  • FDA's oncology advisors vote against 'new paradigm' in AstraZeneca trial
    In its first meeting in about nine months, the FDA’s advisory committee of oncology experts voted 6-3 Thursday that a late-stage trial for AstraZeneca’s oral SERD camizestrant didn't show a “clinic…
    Endpoints · 4mo ago↗ source