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2,261 stories matching this filter · ← front page

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  • 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.
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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
  • STAT+: Treatment for alcohol addiction is undergoing a seismic shift. Many say it’s overdue
    The surging popularity of alternatives to Alcoholics Anonymous represents a seismic shift in the alcohol treatment landscape. Many say it's overdue.
    STAT · 3mo ago↗ source
  • Opinion: Using AI in addiction medicine could be particularly risky
    "AI can make great strides in medical decision support, but unfiltered interaction between agent and patient is dangerous," writes Steve D. Klein.
    STAT · 3mo ago↗ source
  • Hantavirus risk remains low, CDC says, citing its ‘playbook’ response
    Despite rising concern about the hantavirus outbreak on a cruise ship, two CDC doctors say the risk to the public remains low.
    STAT · 3mo ago↗ source
  • Officials say $1.3 billion in Medicaid money to California will be deferred over suspicions of fraud
    Vice President JD Vance announced a $1.3 billion deferral in Medicaid reimbursements to California, as part of an initiative to root out fraud in federal health programs.
    STAT · 3mo ago↗ source
  • Opinion: The hantavirus is a wake-up call. Will the Trump administration answer it?
    Arriving in the isolation ward of a biocontainment hospital is an unsettling, scary experience. In 2014, I spent 19 days in one while being treated for Ebola, watching the news…
    STAT · 3mo ago↗ source
  • #ASGCT26: After an apparent cure, a gene editing company struggles to repeat the magic
    BOSTON — Early last year, startup iECURE’s experimental gene therapy seemingly cured a baby of a life-threatening genetic disease. But new results testing the same therapy in a larger number of bab…
    Endpoints · 3mo ago↗ source
  • Takeda to target 4,500 jobs as incoming CEO continues restructuring
    Takeda will cut roughly 9% of its workforce over the next fiscal year as the next CEO puts her stamp on a yearslong restructuring. About 4,500 roles will be affected, the company said Wednesday in ...
    Endpoints · 3mo ago↗ source
  • Opinion: Hospitals are silencing doctors online, and it’s fueling the health misinformation crisis
    Hospitals and health systems need to loosen the reins and let physicians combat social media misinformation, writes Adam Goodcoff.
    STAT · 3mo ago↗ source
  • Valneva to cut up to 15% of jobs as reduced travel hits vaccine demand
    French vaccine maker Valneva is laying off 10% to 15% of its workforce and reducing revenue projections due to "an emerging adverse trend in travel vaccine uptake across key markets." The drugmaker
    Endpoints · 3mo ago↗ source
  • STAT+: What the Trump administration wants in its next FDA leader
    Leaders want the next FDA commissioner to be someone who can rebuild trust, focus on food policy, and drive drug-approval reforms.
    STAT · 3mo ago↗ source
  • U.S. overdose deaths fell again in 2025, but some worry about policy and drug supply changes
    About 70,000 Americans died of drug overdoses last year — about 14% fewer than the previous year, according to preliminary government data.
    STAT · 3mo ago↗ source
  • FDA’s leadership void leaves biotech with renewed ‘uncertainty’
    Marty Makary's resignation leaves the agency with temporary directors in three top positions, and a number of newly instituted policies with an unclear future.
    BioPharma Dive · 3mo ago↗ source
  • Abeona pivots to T cells; AstraZeneca's rare disease drug passes Phase 3
    Plus, news about Amicus Therapeutics, Fosun Pharma, Duality Biotherapeutics, BioNTech and C4 Therapeutics. 👁️ Abeona drops eye gene therapies, pivots to solid tumor T cell therapy: The biotech, wh…
    Endpoints · 3mo ago↗ source
  • Lilly data point to ‘maintenance’ strategies for GLP-1 weight loss
    A pair of trial results published in medical journals suggest switching from high-dose injectables to lower doses or pills could help people with obesity keep their weight down over the long term.
    BioPharma Dive · 3mo ago↗ source
  • Medicare halts enrollment of new hospice, home health providers
    The Centers for Medicare and Medicaid Services said it will pause the enrollment of new hospice and home health providers.
    STAT · 3mo ago↗ source
  • The ‘velocity of obesity’ aims to show which nations are slowing an epidemic
    A study finds the rise in U.S. obesity rates have hit a plateau in children but are still climbing for adults, and are still high compared to those in other…
    STAT · 3mo ago↗ source
  • Post-Hoc: Why FDA Commissioner Marty Makary was ousted
    Marty Makary never stood a chance. Over the last few days, the now-former FDA commissioner had been left to twist in the wind, after headlines emerged late last week that President Donald Trump had…
    Endpoints · 3mo ago↗ source
  • Assertio accepts new buyout bid; AI biotech Isomorphic banks $2B
    Assertio’s latest offer represents a roughly 31% premium over an initial acquisition proposal. Elsewhere, Kyverna is readying a first-of-its-kind approval application and AC Immune is swapping CEOs.
    BioPharma Dive · 3mo ago↗ source
  • New subpoena suggests DOJ has begun criminal investigation of gender-affirming care
    Several hospitals have received federal grand jury subpoenas regarding gender-affirming care for minors, suggesting a criminal investigation has begun.
    STAT · 3mo ago↗ source
  • STAT+: Gene therapy viruses linked to a boy’s tumor
    The case for Makary as the WOAT, Cassidy's seat at risk ahead of midterms, and other biotech news from The Readout
    STAT · 3mo ago↗ source