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1,796 stories matching this filter · ← front page

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  • Otsuka reports long-term kidney data key to Voyxact's bid for full approval
    Otsuka on Thursday reported new long-term data that it hopes will convert an accelerated approval to a full green light in kidney disease. The company said the Phase 3 study showed Voyxact stabil…
    Endpoints · 24d ago↗ source
  • IPF biotech Celea gets $180M to follow paths of PureTech's Karuna, Seaport
    With major backing from new investors, Celea Therapeutics hopes to follow in the footsteps of its siblings Seaport Therapeutics and Karuna Therapeutics. Celea has corralled $180 million to see if
    Endpoints · 24d ago↗ source
  • Roche KRAS drug succeeds in head-to-head lung cancer study
    <figure><div><img src="https://imgproxy.divecdn.com/Sx5xDgNmDFUjqj0qcGVTS7IkwSLxPHMSmgzypS8Uexg/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xOTM3MjY1MDU5XzEua…
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BioPharma Dive · 24d ago
↗ source
  • STAT+: Roche drug sets new standard for KRAS-driven lung cancer
    Biotech's bull market, Vertex's gene therapy expansion, and more news from The Readout
    STAT · 24d ago↗ source
  • Vertex's sickle cell therapy approved for kids; United Therapeutics buys startup
    🧬 Vertex’s sickle cell gene therapy approved for kids: Casgevy may now be used to treat either sickle cell disease with recurrent vaso-occlusive crises or transfusion-dependent β-thalassemia patie…
    Endpoints · 24d ago↗ source
  • Galderma gets CRL for anti-wrinkle drug; Kimball buys CDMO for $103M
    Plus more from Lonza, Icosagen and others. 🟥 Galderma’s CRL: Galderma has received a complete response letter from the FDA for its relabotulinumtoxinA, a drug being reviewed as a neuromodulator…
    Endpoints · 24d ago↗ source
  • STAT+: Pharmalittle: We’re reading about a court win for Amgen, Novo seeking supplier discounts, and more
    U.S. judge blocked a Colorado state panel from placing a cap on the price of Amgen's blockbuster drug Enbrel
    STAT · 24d ago↗ source
  • How Butterfly, once known for its handheld ultrasound device, is growing its chip-making business
    Nvidia got its start as a gaming chip maker before meteoric success selling its chips to nearly every industry. One health tech company is hoping to go down a similar route. Last month, ultrasoun…
    Endpoints · 24d ago↗ source
  • STAT+: U.S. judge blocks Colorado’s first-of-its-kind price cap on an Amgen drug
    A federal judge blocked a Colorado state panel from placing a cap on the price of Enbrel, a blockbuster drug sold by Amgen
    STAT · 24d ago↗ source
  • STAT+: More frequent, more intense, and longer heat waves pose health risks for Americans
    The presidential fitness test is back, surprising new data on the health risks of obesity, and more Morning Rounds news
    STAT · 24d ago↗ source
  • Roche’s KRAS G12C inhibitor beats rivals in head-to-head Phase 3 study
    Roche’s lung cancer drug candidate divarasib has beaten marketed drugs from Amgen and Bristol Myers Squibb in a head-to-head trial. Full data haven't yet emerged, but if the drug's survival benefit…
    Endpoints · 24d ago↗ source
  • Ex-iTeos CEO starts fresh at GSK neuro partner; Genentech loses yet another key scientist
    → Michel Detheux has succeeded Rita Balice-Gordon as CEO of Danish neuro biotech Muna Therapeutics, which is partnering with GSK on Alzheimer’s treatments. Balice-Gordon will slide over to ...
    Endpoints · 24d ago↗ source
  • BrightGene looks to the West as obesity shot nears China approval
    Armed with impressive Phase 3 data, BrightGene is taking its obesity shot to Chinese regulators. It expects trial data in the West to be even stronger, but its search for a partner for ex-China ter…
    Endpoints · 24d ago↗ source
  • STAT+: Halfway into the year, biotech is booming
    The biotech stock rally that began in April 2025 has not stopped, and if anything, has accelerated.
    STAT · 24d ago↗ source
  • Opinion: Teens are turning to chatbots for mental health help. We need rules to keep them safe
    The share of young people using AI chatbots for mental health advice rose more than 40% in a single year, researcher writes.
    STAT · 24d ago↗ source
  • Opinion: CDC leadership continues to try to manufacture a scientific debate on vaccines where none exists
    CDC leadership continues to try manufacture a scientific debate on vaccines where none exists, writes Ben Lopman.
    STAT · 24d ago↗ source
  • STAT+: A former AI regulator, now in industry, says biopharma is reading FDA’s guidance wrong
    Companies are being too conservative in how they interpret FDA's AI guidance, but the agency can do more to help, too, Tala Fakhouri says.
    STAT · 24d ago↗ source
  • STAT+: A year after distressed buyout, what’s become of Bluebird Bio?
    Bluebird Bio was a dark biotech morality tale when David Meek bought it. He says the new company, Genetix, is already making money.
    STAT · 24d ago↗ source
  • The new presidential fitness test is a positive step, not the solution, experts say
    Physical activity needs to be fun to keep kids engaged. And the test risks embarrassing them, instead.
    STAT · 24d ago↗ source
  • STAT+: A ‘historic’ FDA clearance raises the question: Is the LLM an interface or the decision-maker?
    The newly cleared device is based around an app that helps a patient manage their diabetes using a treatment plan defined by their doctor.
    STAT · 24d ago↗ source
  • Statins and blood pressure drugs changing health risks of obesity, study suggests
    New research shows obesity patients over 40 are managing blood pressure and cholesterol as well as healthy-weight peers, but younger adults remain at risk.
    STAT · 24d ago↗ source
  • Merck scraps a Phase 2 Alzheimer's asset from partner Neuphoria
    Merck has axed a Phase 2 trial testing an experimental Alzheimer’s medicine, Endpoints News has learned. The company terminated a mid-stage test of the oral drug candidate MK-1167, a Merck spokes…
    Endpoints · 25d ago↗ source
  • FDA warns Genzyme's Irish site over quality questions
    An FDA warning letter sent late last month to Genzyme's Ireland-based manufacturing site, now owned by Sanofi, raises significant quality- and data-related issues. On data integrity, the warning…
    Endpoints · 25d ago↗ source
  • WuXi AppTec seeks injunction over China military list
    WuXi AppTec has filed for a preliminary injunction to suspend its place on the Pentagon’s list of companies with alleged ties to the Chinese military. The injunction, dated June 29, seeks to stop…
    Endpoints · 25d ago↗ source
  • FDA approves Orca Bio’s cell therapy to improve transplant outcomes
    The FDA gave the go-ahead to Orca Bio’s T cell therapy that would reduce transplant-related complications for blood cancer patients. The therapy will be branded as Tregzi, an homage to the regula…
    Endpoints · 25d ago↗ source