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3,713 stories matching this filter · ← front page

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  • Skyhawk Therapeutics reports symptom improvement for Huntington's disease in Phase 1/2 extension study
    Skyhawk Therapeutics announced that its RNA-splicing candidate SKY-0515 showed a measurable improvement in symptoms for patients with Huntington's disease during an extension of its Phase 1/2 trial…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Dementia should be a campaign issue, not a political insult, says expert
    Jason Karlawish, a professor at Penn and co‑director of the Penn Memory Center, argues that dementia deserves serious policy focus during the upcoming election. He notes that about 7.1 million Ame…
    STAT · 1mo agoNeutral↗ source
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  • Experts urge more representative enrollment in clinical trials
    A panel of regulators and industry leaders gathered to discuss how clinical trials can better reflect the diversity of patient populations. The discussion included officials from the U.S. Food and…
    raps · 1mo agoRegulatoryNeutral↗ source
  • GOP Bill Seeks to Tilt Medicare Advantage Study Toward Insurers
    Republicans on the House Ways and Means Committee advanced a bill that would direct the Medicare Payment Advisory Commission, MedPAC, to study Medicare Advantage spending in a way that favors insur…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Yale and Harvard faculty question benefits of FDA's 'America First' user fee provisions
    Yale and Harvard medical school faculty have voiced concerns about the latest FDA user fee agreement, which includes a set of "America First" provisions. The provisions are designed to prioritize…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • WHO sees declining Ebola transmission in DRC but warns months of work remain
    The World Health Organization’s director‑general said on Wednesday that transmission rates of Ebola are falling in most provinces of the Democratic Republic of the Congo, offering a reason for caut…
    STAT · 1mo agoPositive↗ source
  • Sen. Warren calls for release of Trump-era pharma pricing contracts amid accusations against RFK Jr.
    Sen. Warren has publicly demanded that the contracts governing drug pricing under the Trump administration be disclosed. She alleges that RFK Jr. is concealing these agreements, raising concerns ab…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • FDA opens applications for pilot program to speed up first-in-human testing
    The U.S. Food and Drug Administration announced that it is now accepting applications for a pilot program designed to shorten the time required for drug developers to begin first‑in‑human clinical…
    STAT · 1mo agoRegulatoryPositive↗ source
  • 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
  • Experts assess EU medical device and diagnostic regulations at RAPS Convergence 2026
    A panel of experts representing the European Commission, industry groups and notified bodies gathered in Charlotte, North Carolina during RAPS Convergence 2026. The group reviewed the current stat…
    raps · 1mo agoRegulatoryNeutral↗ source
  • 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
  • Saratoga Potato Chips recalls J. HIGGS Loaded Bacon & Cheddar chips over undeclared soy allergen
    Saratoga Potato Chips of Fort Wayne, Indiana announced a recall of two best‑if‑used‑by codes of its 7.75‑ounce J. HIGGS Loaded Bacon and Cheddar potato chips because the product may contain undecla…
    fda recalls · 1mo agoCRLNeutral↗ 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
  • 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 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