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2,025 stories matching this filter · ← front page

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  • Experts warn of deaths linked to Neurocrine's Vykat XR for Prader-Willi syndrome
    A coalition of specialists in Prader-Willi syndrome has raised serious concerns about the safety profile of Neurocrine Biosciences' drug Vykat XR. The experts point to a series of adverse events,…
    Endpoints · 4h agoRegulatoryNegative↗ source
  • Study finds cancer patients now wait longer for treatment than a decade ago
    A new analysis of more than 2.7 million cancer cases shows that the interval between diagnosis and the start of therapy has grown over the past ten years. The researchers examined records from a na…
    STAT · 8h agoNegative↗ source
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  • Neurocrine's Prader-Willi drug Vykat XR linked to multiple deaths and serious side effects
    A group of physicians and experts in Prader-Willi syndrome warned clinicians about safety concerns with Vykat XR, a drug approved by the FDA in March 2025 to reduce the intense hunger in patients w…
    STAT · 14h agoRegulatoryNegative↗ source
  • AI monitoring tool could generate up to 82-fold ROI in phase-3 oncology trials, study finds
    An analysis by the Tufts Center for the Study of Drug Development found that an artificial-intelligence clinical monitoring agent can produce an estimated 82-fold return on investment in phase-3 on…
    Fierce Biotech · 9h agoPositive↗ source
  • AbCellera, Silence and InduPro secure major funding rounds as AbCellera completes $200M share sale
    Vancouver based biotech AbCellera announced a $200 million share offering after meeting its efficacy targets in a Phase 2 hot flashes trial. The capital raise follows the company achieving its pred…
    Endpoints · 7h agoDealPositive↗ source
  • Definium's LSD pill shows significant anxiety reduction in Phase 3 trial
    Definium Therapeutics announced results of a Phase 3 trial testing its LSD‑based pill DT120 in patients with generalized anxiety disorder. The study enrolled 214 participants who received a single…
    STAT · 11h agoPositive readoutPositive↗ source
  • WHO and DRC move to fast-track Phase 3 Ebola vaccine trial, starting with Merck’s Ervebo
    The World Health Organization and authorities in the Democratic Republic of the Congo are negotiating to speed up the launch of a multi‑armed Phase 3 trial of Ebola vaccines. The effort targets th…
    STAT · 2h agoCRLPositive↗ source
  • Fifth Circuit Court Rules in Favor of Providers on No Surprises Act Arbitration, May Increase Payments
    The U.S. Court of Appeals for the Fifth Circuit issued a decision that sides with health-care providers in a lawsuit over the No Surprises Act. The case stemmed from a 2022 Texas Medical Associati…
    STAT · 2h agoRegulatoryPositive↗ source
  • WHO calls Trump’s vaccine policy order misguided, warns it could increase needle shots and disease risk for children
    WHO Director-General Tedros Adhanom Ghebreyesus and other senior officials criticized a new U.S. executive order that seeks to overhaul the childhood vaccination schedule. The order, signed by Pre…
    STAT · 5h agoRegulatoryNegative↗ source
  • FDA outlines new onshoring incentives and meeting types for generic drug applicants under GDUFA IV
    The FDA released its GDUFA IV commitments, indicating that review timelines for generic drug submissions will remain largely consistent through 2032, mirroring the schedule of the previous five yea…
    Endpoints · 5h agoRegulatoryNeutral↗ source
  • Lilly sues over black-market retatrutide; Neurocrine's new obesity drug linked to patient deaths
    Eli Lilly has filed six lawsuits against U.S. companies it says are illegally selling black-market versions of its experimental obesity drug retatrutide. The company alleges the defendants are dist…
    STAT · 9h agoRegulatoryNegative↗ source
  • Definium's oral LSD candidate passes first Phase 3 trial in generalized anxiety disorder
    Definium Therapeutics announced that its oral LSD candidate has successfully completed a Phase 3 trial in generalized anxiety disorder. The study met its primary endpoints, marking the first of tw…
    Endpoints · 12h agoPositive readoutPositive↗ source
  • Boulevard Bio raises $65M to expand immunology pipeline, eyes Vera's IgAN candidate
    Boulevard Bio announced it has secured $65 million in financing to broaden its immunology portfolio. The new capital will support the development of two immune‑resetting drugs the company discovere…
    Endpoints · 12h agoDealPositive↗ source
  • Samsung gets FDA clearance for Galaxy Buds hearing-aid features
    Samsung Electronics received FDA clearance for new software features in its Galaxy Buds earphones that let them function as over-the-counter hearing aids and conduct hearing tests. The hearing tes…
    Fierce Biotech · 15h agoApprovalPositive↗ source
  • White House rolls out treatment-first addiction toolkit emphasizing faith-based care and abstinence
    The Trump administration introduced a new framework for addressing addiction and homelessness, called a "treatment-first" toolkit. The toolkit prioritizes medical treatment and faith-based program…
    STAT · 3h agoRegulatoryNeutral↗ source
  • Eli Lilly sues six U.S. firms over alleged black-market sales of investigational drug retatrutide
    Eli Lilly has filed lawsuits against six U.S. companies it says are selling its investigational diabetes and weight-loss drug retatrutide. The companies are accused of operating a black-market for…
    Endpoints · 6h agoNegative↗ source
  • Commure's AI-driven referral program draws complaints of financial losses from health-care customers
    Commure, a Silicon Valley startup valued at $7 billion, builds AI tools aimed at automating health‑care administrative work such as scheduling, billing and prior‑authorization. According to intern…
    STAT · 14h agoNegative↗ source
  • Climate change worsens symptoms for people with chronic illnesses, author reports from Chicago smoke events
    The author argues that climate change is already harming health, particularly for those living with chronic conditions, and that the impact is becoming more evident. She describes a recent summer…
    STAT · 14h agoNegative↗ source
  • Vaping and cannabis use hit record highs among U.S. young adults in 2025, survey finds
    A new national survey by the University of Michigan shows vaping and cannabis use among U.S. young adults reached record levels in 2025. Past‑30‑day nicotine vape use rose to 19%, more than triple…
    STAT · 2h agoNegative↗ source
  • Vaccine makers say splitting MMR vaccine is impractical despite presidential directive
    Vaccine manufacturers responded to a recent order from President Donald Trump to separate the combined measles, mumps and rubella (MMR) vaccine, noting that while the concept is theoretically possi…
    Endpoints · 4h agoNeutral↗ source
  • Postpartum psychiatry remains inadequately understood, case of Lindsay Clancy highlights gaps
    The opinion piece, authored by a neuroscience professor at Tufts, an obstetrics‑psychiatry specialist at NewYork‑Presbyterian and Weill Cornell, and a psychiatry researcher at the University of Vir…
    STAT · 8h agoNegative↗ source
  • Renowned autoimmune researcher Georg Schett co-founds biotech to develop antibody therapies
    Georg Schett, a German scientist noted for pioneering CAR‑T approaches in autoimmune disease, is now launching a new biotech venture. The startup, which has not yet been named in the report, will…
    STAT · 12h agoDealPositive↗ source
  • Endpoints News recaps Boston China biotech debate on industry’s China outlook
    Last week Endpoints News hosted a live debate in Boston that brought together leading voices in biopharma to discuss China’s growing role in the industry. The panel featured executives and investo…
    Endpoints · 7h agoNeutral↗ source
  • Inside a Secret AI Startup: Challenges of Building and Selling Clinical Tools
    The STAT+ newsletter reveals that a health‑tech reporter has been quietly developing an artificial‑intelligence startup for the past six months. The piece describes the difficulties of rapidly cre…
    STAT · 10h agoNeutral↗ source
  • Oma's Pride recalls one lot of Woof Complete Canine Chicken Recipe due to possible Salmonella contamination
    Oma's Pride of Avon, Connecticut announced a voluntary recall of a single lot (BB012729) of its 6‑lb Woof Complete Canine Chicken Recipe pet food after testing identified Salmonella contamination.…
    fda recalls · 1h agoRegulatoryNegative↗ source