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3,898 stories matching this filter · ← front page

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  • Senators probe nominee Chris Klomp’s influence on HHS health-policy and drug pricing
    Senators on the Finance and Energy committees held two days of hearings to examine the authority that Chris Klomp would have if confirmed as deputy secretary of HHS. Klomp, a senior adviser who se…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Democrats pledge to use oversight powers to push health-care reforms if they win Congress
    House Democrats say they will employ congressional oversight to advance a health-care overhaul should they gain control of the House or Senate. They intend to focus on health-care topics, includin…
    STAT · 1mo agoRegulatoryNeutral↗ source
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  • Professor uses his own thymic cancer journey to teach medical students about real-world oncology
    David Elkowitz, a professor of pathology and laboratory medicine at Hofstra/Northwell, writes about how his personal battle with thymic cancer shapes his teaching. He now brings his own case into…
    STAT · 1mo agoPositive↗ source
  • Novartis to pay $125M for blood-brain barrier crossing platform
    Proceeds from the deal, which hands Novartis global rights to a technology developed by Sironax, will help advance three candidates that the startup says have “best-in-class” potential.
    BioPharma Dive · 1mo ago↗ source
  • Sling banks $123M for an experimental thyroid eye disease pill
    A confirmatory late-stage study is now also underway for what the startup is positioning as, potentially, the first oral alternative to approved injectables like Amgen's Tepezza and Viridian's Lumvoa.
    BioPharma Dive · 1mo ago↗ source
  • FDA approves first generic radioligand therapy for neuroendocrine tumors as Sionna announces major layoffs
    The U.S. Food and Drug Administration has cleared Bexlutry, the first generic version of Novartis’ Lutathera, marking the debut of a radioligand therapy that can be used for SSTR‑positive neuroendo…
    BioPharma Dive · 1mo agoApprovalNeutral↗ source
  • Vera Therapeutics' Trutakna shows kidney function stabilization and lower death risk in Phase 3 IgAN trial
    Vera Therapeutics reported that its drug Trutakna met its primary goals in a two‑year Phase 3 study of patients with IgA nephropathy. The therapy stabilized kidney function and lowered the risk of…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Fourth measles death reported in Pennsylvania, all victims unvaccinated
    Pennsylvania health officials reported a fourth measles-associated death in the state, involving an 18-year-old from Mifflin County. The death was caused by acute disseminated encephalomyelitis, a…
    STAT · 1mo agoNegative↗ source
  • New antibody-drug conjugates show promise as potential standard for extensive-stage small cell lung cancer at WCLC 2026
    The World Conference on Lung Cancer showcased several late‑stage trial updates, with a focus on new therapies for small cell lung cancer, the more aggressive form of the disease. Antibody‑drug con…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Vera Therapeutics reports two-year data showing Trutakna stabilizes kidney function in IgA nephropathy, paving way for full FDA approval
    Vera Therapeutics announced that its recently approved drug Trutakna has produced encouraging two-year results in patients with IgA nephropathy, a chronic autoimmune kidney disease. The data indic…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • RegCell secures multi-million dollar Series A to advance Nobel-winning regulatory T-cell therapy
    RegCell, a biotech founded by Nobel laureate Shimon Sakaguchi, announced a new financing round to move its regulatory T-cell (Treg) program toward clinical testing. The company’s CEO Michael McCul…
    Endpoints · 1mo agoDealPositive↗ source
  • Medicare AI prior-authorization pilot plagued by rollout glitches, causing care delays
    Documents obtained through a Freedom of Information Act lawsuit reveal that the Medicare program using artificial intelligence for prior authorization was launched hastily and suffered numerous tec…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Medicare expands ACCESS pilot to cover more chronic conditions with outcome-based payments
    Medicare's ACCESS model, a pilot that pays technology providers for managing chronic diseases, is being broadened. Initially covering diabetes, hypertension, chronic musculoskeletal pain, depressi…
    STAT · 1mo agoRegulatoryPositive↗ source
  • FDA launches expedited IND pilot program, integrating public feedback into qualification criteria
    The FDA announced that its long-awaited expedited investigational new drug (IND) pilot program has started accepting applications as of Tuesday. Agency leaders Karim Mikhail and Michael Davis, new…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Axoltis reports Phase 2 failure of experimental ALS drug but notes small signal
    Axoltis Pharma, a French biotech, announced that its Phase 2 trial of an experimental ALS therapy did not meet its primary endpoints. The company said the data were noisy but observed a modest tre…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • FDA launches pilot to accelerate early-stage drug trials in the United States
    The FDA announced a new pilot program called the Expedited Investigational New Drug Pilot as part of Operation Trialblazer. The initiative will pair up to ten qualified research institutions with…
    BioPharma Dive · 1mo agoRegulatoryPositive↗ source
  • FDA opens pilot program to speed human testing of new drugs
    The Food and Drug Administration announced it is accepting applications for a pilot under Operation TrialBlazer aimed at reducing the time before drug candidates can start human trials. The initia…
    STAT · 1mo agoRegulatoryPositive↗ source
  • FDA Opens Expedited IND Pilot to Speed First-in-Human Trials, Applications Accepted Through Oct. 30
    The U.S. Food and Drug Administration announced the final design of an Expedited IND Pilot aimed at shortening the time from drug discovery to first-in-human trials. The pilot pairs drug developer…
    fda press · 1mo agoRegulatoryNeutral↗ source
  • New documents expose flaws in Medicare’s rushed AI prior-authorization pilot
    New internal documents have highlighted serious shortcomings in Medicare’s recently launched AI-driven prior‑authorization pilot, which was rolled out faster than anticipated. The pilot, designed…
    STAT · 1mo agoRegulatoryNegative↗ source
  • J&J and Contineum's oral M1 inhibitor fails second mid-stage depression trial
    Contineum Therapeutics and Johnson & Johnson reported that their oral M1 receptor inhibitor, known as PIPE-307 or JNJ-5120, did not meet its primary endpoints in a Phase II study for major depressi…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Exercise and echocardiograms helped keep astronauts’ hearts stable during six-month spaceflight, study finds
    A team of international researchers examined 13 astronauts who spent six months aboard the International Space Station. The crew underwent regular onboard echocardiograms to monitor heart size and…
    STAT · 1mo agoPositive readoutPositive↗ source
  • FDA approves first radioligand generic, pitting Curium against Novartis' Lutathera
    The U.S. Food and Drug Administration has granted approval to Curium’s radioligand product, the first generic in this therapeutic class. The approved drug is a direct equivalent of Novartis’ Lutat…
    Endpoints · 1mo agoApprovalNeutral↗ source
  • Centric Compounding initiates nationwide recall of three injectable drugs due to API contamination
    Centric Compounding, a Houston-based pharmacy, announced a nationwide recall of three injectable products after detecting contamination in an active pharmaceutical ingredient. The recall includes…
    Endpoints · 1mo agoCRLNegative↗ source
  • GSK to close German vaccine plant and cut 650 jobs as flu vaccine demand falls
    GSK announced it will wind down its vaccine manufacturing site in Germany, ending operations at the facility. The decision follows a rigorous review and reflects a decline in demand for egg‑based…
    Endpoints · 1mo agoLayoffsNegative↗ source
  • Legend Biotech appoints former Novartis executive as CEO while Vera pursues full approval for kidney drug
    Legend Biotech announced that Ingrid Zhang, a former Novartis executive, will take over as chief executive officer, replacing Ying Huang who stepped down in July. Vera reported that its recently l…
    STAT · 1mo agoNeutral↗ source