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3,107 stories matching this filter · ← front page

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  • Acelyrin founder Shao-Lee Lin emerges at Cue, as it becomes latest to license from China
    Cue Biopharma announced a reboot Thursday afternoon, bringing in notable biotech executive Shao-Lee Lin as well as a new allergy asset developed in Taiwan and mainland China. The Boston-based biote…
    Endpoints · 4mo ago↗ source
  • Save the date: Premium subscriber-exclusive Post-Hoc Live
    Q1 earnings recap with Endpoints News After a deal-heavy first quarter, earnings season is in full swing. We're breaking down the news and trends from Big Pharma's first-quarter calls on a special…
    Endpoints · 4mo ago↗ source
  • FDA approval for Alzheimer's agitation drug; Esperion goes private in $1.1B deal
    🟢 FDA approves Axsome Therapeutics' Auvelity for Alzheimer’s agitation: Axsome said up to 76% of patients with Alzheimer’s disease have agitation, which is characterized by pacing, restlessness an…
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Endpoints · 4mo ago
↗ source
  • Bristol Myers’ legacy lift, Biogen’s blue skies and Regeneron’s murky outlook
    Investors are still waiting to see whether Bristol Myers and Regeneron’s pipelines will deliver, while Biogen was lifted by better-than-expected results for newer drugs like Leqembi and Skyclarys.
    BioPharma Dive · 4mo ago↗ source
  • STAT+: Axsome wins FDA nod for Alzheimer’s agitation
    Vinay Prasad's acting replacement, remembering genomics pioneer J. Craig Venter, and more biotech news from The Readout
    STAT · 4mo ago↗ source
  • STAT+: Pharmalittle: We’re reading about obesity drugs and a compounding list, an AstraZeneca setback, and more
    The FDA proposed excluding the active ingredients in popular obesity and diabetes drugs from a list of substances that can be used for compounded versions
    STAT · 4mo ago↗ source
  • PFAS is still in some infant formula
    Casey Means out as surgeon general nominee, America's renewed fertility anxiety, and more health news
    STAT · 4mo ago↗ source
  • Summit slips on ivonescimab's apparent interim miss in sign of investor frustration
    Summit Therapeutics’ stock price {$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
  • Krazati fails confirmatory trial in colorectal cancer, putting approval at risk
    Bristol Myers Squibb’s cancer drug Krazati has failed its confirmatory study in second-line colorectal cancer, a company spokesperson confirmed to Endpoints News. Krazati had received accelerated a…
    Endpoints · 4mo ago↗ source
  • House panel calls to ban China data from FDA drug trial applications
    A powerful spending committee in Congress wants the FDA to ban the use of clinical trial data from China in future applications by drugmakers to test new treatments. The language was
    Endpoints · 4mo ago↗ source