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1,598 stories matching this filter · ← front page

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  • Type 1 diabetes pipeline making ‘remarkable progress’ toward insulin independence
    After the trailblazing approval of Sanofi’s Tzield for stage 3 type 1 diabetes, several companies, including SAB Biotherapeutics and Eledon Pharmaceuticals, are vying for a spot in the landscape wi…
    BioSpace · 1mo agoApprovalPositive↗ source
  • Medicare proposes cuts to hospital payments for drugs and imaging under new outpatient rule
    Medicare's Centers for Medicare & Medicaid Services released a proposed rule that would lower the amounts hospitals receive for certain prescription drugs and imaging services provided to Medicare…
    STAT · 1mo agoRegulatoryNegative↗ source
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  • Vertex’s IgA nephropathy drug povetacicept gains momentum as FDA reviews it after Novartis and Vera approvals
    Vertex Pharmaceuticals’ povetacicept is currently under FDA review with a target action date of Nov. 30 for the treatment of IgA nephropathy. The FDA recently granted full approval to Novartis’ Fa…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • UK regulator reports rise in drug approvals and new AI healthcare regulations
    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) released its 2025-2026 annual report to Parliament. The agency highlighted that it approved more new medicines in the past year…
    raps · 1mo agoRegulatoryPositive↗ source
  • Study finds China approved more cancer drugs than US between 2020-2025, but US led in first-in-class and speed
    A new analysis published in Health Affairs compares oncology drug approvals by China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) from 2020 thro…
    raps · 1mo agoRegulatoryNeutral↗ source
  • UK regulator reports rise in drug approvals and steps to regulate AI in healthcare
    The Medicines and Healthcare products Regulatory Agency (MHRA) presented its 2025-2026 annual report to Parliament, highlighting a higher number of new drug approvals compared with the previous yea…
    raps · 1mo agoRegulatoryPositive↗ source
  • FDA’s push to publish complete response letters faces legal uncertainty and possible pause
    The FDA began releasing complete response letters (CRLs) to the public last year, a move promoted as increasing transparency for drug developers, investors, and patients. However, the policy has e…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Former staff allege LifeMD prioritized GLP-1 prescription volume over patient safety
    Novo Nordisk lists telehealth firm LifeMD on its website as a provider that offers legitimate medicine sourcing and patient support for individuals seeking GLP-1 drugs such as Ozempic and Wegovy.…
    STAT · 1mo agoNegative↗ source
  • Bristol Myers Squibb announces construction of pharma’s largest NVIDIA AI supercomputer
    Bristol Myers Squibb (BMS) said it is building what it calls the largest AI supercomputer in the life‑science sector, marking the third such claim by a drugmaker in nine months. The effort expands…
    STAT · 1mo agoPositive↗ source
  • Former LifeMD staff say company pushed rapid GLP-1 prescriptions at expense of patient safety
    Former employees of telehealth firm LifeMD allege the company encouraged clinicians to see more patients and issue weight‑loss drug prescriptions quickly, with limited screening or follow‑up. Five…
    STAT · 1mo agoNegative↗ source
  • Iowa audit finds PBM kept over $100 million by inflating Medicaid drug costs
    A recent audit of Iowa's Medicaid program uncovered that a major pharmacy benefit manager used complex claim handling methods that led to higher costs for the state. The review of records from 201…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Kyverna Therapeutics aims to file first CAR-T cell therapy for autoimmune disease
    Kyverna Therapeutics is preparing what could become the first regulatory filing for a CAR-T cell therapy targeting an autoimmune condition. The company has been developing its miv-cel construct in…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • HHS vaccine committee receives new charter amid broader health policy updates
    The U.S. Health and Human Services vaccine advisory panel has been granted a new charter, a change that was noted quietly in a recent health newsletter. The same briefing highlighted other policy…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Pandemics Should Be Treated as National Security Threats, Experts Argue
    In an opinion piece, David Blumenthal and James A. Morone argue that pandemics should be classified and addressed as national security threats rather than solely health-care challenges. They note…
    STAT · 1mo agoPositive↗ source
  • FDA maintains focus on Taylor Farms lettuce as source of cyclospora outbreak despite false‑positive test
    Federal health officials said on Monday that the FDA continues to target shredded lettuce from Taylor Farms as the likely source of a multistate cyclospora outbreak, even after a laboratory result…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Physician blames U.S. health insurance failures after husband's suicide
    Joy Evers, an emergency physician, recounts the death of her husband Randy by suicide, describing how she expected her family’s high-quality commercial health insurance to ensure he received timely…
    STAT · 1mo agoNegative↗ source
  • Australia's TGA opens consultation to revamp rules for digital mental health tools
    The Therapeutic Goods Administration (TGA) has launched a public consultation aimed at updating the regulatory framework that governs digital mental health tools in Australia. The move seeks to cla…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Fugitive ex-doctor arrested after two decades posing as biotech executive
    Federal and Rhode Island authorities arrested Ronald Fischer, 70, after tracking a 56-foot sailboat off New Jersey. He had been on the run for about 20 years. Fischer, a former anesthesiologist, v…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Zen Principle Moringa Capsules Recalled Over Possible Salmonella Contamination
    Relay Peak Research LLC, operating as Zen Principle Naturals, announced a voluntary recall of its Zen Principle brand Moringa Leaf Powder Capsules. The recall was triggered by a potential contamin…
    fda recalls · 1mo agoCRLNegative↗ source
  • Yusol International expands recall of Ola-Ola Pounded Yam to include 2-, 4-, 5-, and 10-lb packages over undeclared milk allergen
    Fayus Inc., operating as Yusol International Foods in Sacramento, announced an expanded recall of its Ola-Ola Pounded Yam product line. The recall now covers 2‑lb, 4‑lb, 5‑lb and 10‑lb packages af…
    fda recalls · 1mo agoCRLNegative↗ source
  • U.S. Military's New Testosterone Screening Raises Health Concerns
    The Department of Defense announced a mandatory testosterone screening program for all service members, prompting discussion among medical experts. A urologist who studies men’s health cautions th…
    STAT · 1mo agoNegative↗ source
  • STAT invites reader letters on primary care value, obesity as disease and broader health-care debates
    STAT’s First Opinion platform encourages readers to submit letters responding to its essays, fostering open, good‑faith discussion about health‑care topics. Recent letters, echoing comments from t…
    STAT · 1mo agoNeutral↗ source
  • Sonothera reports ultrasound method delivers high levels of dystrophin in monkeys, a potential new route for Duchenne therapy
    A California startup, Sonothera, is proposing an ultrasound‑based approach to deliver genes for Duchenne muscular dystrophy treatment. The company says its technology can introduce full-size dystr…
    STAT · 1mo agoPositive readoutNeutral↗ source
  • Medicare proposal would boost doctor pay for smoking and alcohol counseling by 19%
    A proposed change to Medicare’s physician fee schedule would increase reimbursement for doctors who provide counseling on tobacco cessation and alcohol or substance misuse. The proposal adds a 19%…
    STAT · 1mo agoRegulatoryPositive↗ source
  • India’s life-sciences sector faces scaling hurdles despite rapid innovation growth, report says
    India’s life‑sciences sector has shown rapid growth, according to a new report by Boston Consulting Group and HealthKois. Patent filings have risen more than four‑fold since 2016, the pipeline of i…
    BioSpace · 1mo agoNeutral↗ source