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2,256 stories matching this filter · ← front page

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  • #ASGCT26: Encoded's gene therapy reduced seizures in Dravet syndrome
    A gene therapy designed by Encoded Therapeutics reduced seizures by 76% in children with Dravet syndrome, a severe neurodevelopmental disorder. The remarkable reduction was observed only in three p…
    Endpoints · 3mo ago↗ source
  • STAT investigates the epidemic killing 178,000 Americans a year
    Read Executive Editor Rick Berke's letter to STAT readers on "The Deadliest Drug," a new investigative series into the country's failure to address excessive alcohol use.
    STAT · 3mo ago↗ source
  • #ASGCT26 dispatch: In vivo CAR-T is everywhere
    BOSTON — Greetings from Boston, where I’ve been on the ground covering the American Society of Gene & Cell Therapy’s annual meeting all week. It’s a crucial moment for the field. Genetic medicine d…
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fda recalls47
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fda press28
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Endocrinology & Metabolism382
Pain376
Infectious Disease356
Endpoints · 3mo ago
↗ source
  • STAT+: CDC plans to transfer monkeys to nonprofit’s sanctuary as it seeks to reduce animal testing
    The CDC intends to transfer more than 160 macaques to Born Free USA, a nonprofit that runs a large primate sanctuary in Texas, as the agency seeks to phase out…
    STAT · 3mo ago↗ source
  • STAT+: The hunt for FDA’s next leader
    Marty Makary is out, and the Trump administration has a long wish list for its next FDA commissioner.
    STAT · 3mo ago↗ source
  • STAT+: MIT says research has fallen 10%, and grad student enrollment is down
    At MIT, research has shrunk 10% from a year ago, and the school expects a persistent drop in graduate admissions.
    STAT · 3mo ago↗ source
  • Create Medicines raises $122M to bolster in vivo CAR-T therapies
    The fresh funds will support the biotech's pipeline of RNA-based CAR-T cell therapies for cancer and autoimmune conditions.
    BioPharma Dive · 3mo ago↗ source
  • Drugmakers have to go through rigorous tests to get a lower tariff rate
    Landing a reduced 20% tariff rate will require pharma companies to fill out extensive paperwork and be closely monitored by the Department of Commerce. President Donald Trump signed an executive or…
    Endpoints · 3mo ago↗ source
  • Biogen pushing tau drug forward despite Alzheimer’s study failure
    One of the company’s more closely watched research assets, BIIB080 is now heading to late-stage testing based on “the strength of the biomarker and efficacy data” seen in a Phase 2 trial.
    BioPharma Dive · 3mo ago↗ source
  • Degron, CREATE, TenNor raise capital; Cabaletta posts CAR-T data
    💸 A Series A extension: US-China biotech Degron Therapeutics has collected an additional $40 million for its molecular glue degrader platform. The San Diego and Shanghai biotech has raised $95 mil…
    Endpoints · 3mo ago↗ source
  • AstraZeneca follows Merck with Phase 3 win in bladder cancer
    A combination of AstraZeneca's Imfinzi with Pfizer and Astellas’ Padcev kept more bladder cancer patients alive than standard of care, the company said Thursday. AstraZeneca said it would seek appr…
    Endpoints · 3mo ago↗ source
  • STAT+: BeOne wins FDA approval in lymphoma race
    Diamantas takes the reins, Regenxbio stakes claim in Duchenne gene therapy, and more biotech news from The Readout
    STAT · 3mo ago↗ source
  • MacroGenics sells manufacturing arm; West Pharma discloses cybersecurity attack
    Plus, news about Bavarian Nordic and OrganaBio’s new CDMO subsidiary: 🏭 Bora buys MacroGenics' manufacturing operations: MacroGenics is selling its clinical and commercial drug substance productio…
    Endpoints · 3mo ago↗ source
  • STAT+: Why big digital health players are missing from Medicare’s chronic care experiment
    In this edition of STAT Health Tech: Why big digital health players skipped Medicare's ACCESS pilot, Isomorphic's big raise, and more.
    STAT · 3mo ago↗ source
  • STAT+: Pharmalittle: We’re reading about upbeat results for a Duchenne drug, Takeda layoffs, and much more
    Biogen reported mixed results from a mid-stage clinical trial investigating a treatment for Alzheimer’s disease that targets the protein tau
    STAT · 3mo ago↗ source
  • With new data, Regenxbio to seek FDA approval of Duchenne gene therapy
    Though two serious side effects muddied the results, CEO Curran Simpson expressed optimism about a clearance and claimed FDA leadership will have a “mandate on rare disease flexibility.”
    BioPharma Dive · 3mo ago↗ source
  • How Penn Medicine plans to use AI to train their doctors
    Physicians at Penn Medicine said they're thinking of how to use AI to train doctors. The idea came out of a $1.1 million grant Penn Medicine won in January through an education grant program with ...
    Endpoints · 3mo ago↗ source
  • STAT+: Three years of declining overdose deaths begets cautious optimism and some concerns
    The next FDA leader, how the CDC is responding to hantavirus, and more health news from Morning Rounds
    STAT · 3mo ago↗ source
  • Biogen's anti-tau Alzheimer's drug misses Phase 2 goal, but claims signs of efficacy
    Here we go again? Biogen reported heavily anticipated Alzheimer’s data, saying its tau-targeting drug BIIB080 missed its primary endpoint in a Phase 2 study but slowed patients’ clinical decline at…
    Endpoints · 3mo ago↗ source
  • STAT+: Biogen’s tau-targeting Alzheimer’s drug posts mixed results in mid-stage study
    Biogen is moving its tau-targeting Alzheimer's drug into Phase 3 studies, despite mixed data from a Phase 2 trial.
    STAT · 3mo ago↗ source
  • Regenxbio hits Duchenne gene therapy milestone, eyes 2027 FDA approval
    Regenxbio said Thursday that its Duchenne muscular dystrophy gene therapy met the bar in a pivotal study, and it’s aiming for FDA approval in 2027. The biotech hopes to be the second company to com…
    Endpoints · 3mo ago↗ source
  • STAT+: CREATE Medicines, a biotech company developing CAR-T therapies, raises $122 million
    CREATE Medicines has a new name, an expanded pipeline, and now fresh funding to propel the company’s first CAR-T candidates through human trials.
    STAT · 3mo ago↗ source
  • STAT+: Regenxbio says Duchenne gene therapy succeeded in clinical trial, paving way for FDA submission
    Regenxbio said its experimental gene therapy for Duchenne muscular dystrophy succeeded in a trial, paving the way for a submission to the FDA.
    STAT · 3mo ago↗ source
  • BeOne’s next-gen BCL2 inhibitor wins FDA approval, taking aim at Venclexta
    BeOne Medicines has clinched an accelerated approval for its drug sonrotoclax in mantle cell lymphoma (MCL), marking the start of its bid to challenge AbbVie and Roche's Venclexta across a range of…
    Endpoints · 3mo ago↗ source
  • STAT+: ‘No drama’ Diamantas should serve biotech well as acting FDA chief
    Kyle Diamantas, the acting commissioner of the FDA, is expected to be a drama-free, stabilizing caretaker at the top of the agency.
    STAT · 3mo ago↗ source