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2,327 stories matching this filter · ← front page

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  • Melanoma patient shares hope after receiving Merck-Moderna mRNA cancer vaccine in trial
    A schoolteacher diagnosed with melanoma in 2019 participated in a late‑stage trial testing an mRNA cancer vaccine developed by Merck and Moderna. The trial added the vaccine to standard immunothera…
    STAT · 25d agoPositive↗ source
  • Kenya confirms second Ebola case as Congo outbreak continues
    Kenya health officials have confirmed a second case of Ebola in the country, raising concerns about potential spread. The report comes as the neighboring Democratic Republic of Congo continues to…
    STAT · 25d agoNegative↗ source
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FDA issues early alert on Edwards Lifesciences transcatheter mitral valve delivery system after balloon burst reports
The FDA's Center for Devices and Radiological Health issued an early alert about a potential high‑risk issue with certain Edwards Lifesciences delivery systems used in the SAPIEN M3 transcatheter m…
fda medwatch · 26d agoRegulatoryNegative↗ source
  • Compass Pathways CEO says company will proceed cautiously as it readies psychedelic therapy for FDA review
    Compass Pathways chief executive Kabir Nath told reporters at the STAT Summit that the company will "go slow before we go fast," emphasizing that early negative experiences could hurt the emerging…
    STAT · 26d agoRegulatoryNeutral↗ source
  • FDA issues warning letters to manufacturers over CGMP and GLP violations
    The U.S. Food and Drug Administration has sent warning letters to multiple drug manufacturers for failing to meet current good manufacturing practice requirements. The agency highlighted problems e…
    raps · 26d agoRegulatoryNegative↗ source
  • Former FDA commissioners slam current HHS leadership over research cuts and regulatory challenges
    Former FDA commissioners Rob Califf, Scott Gottlieb and Ned Sharpless publicly criticized the officials running the agency, saying the current HHS leadership is failing the FDA. They highlighted m…
    STAT · 25d agoRegulatoryNegative↗ source
  • Verastem reports encouraging early data for KRAS G12D inhibitor in pancreatic cancer
    Verastem Oncology disclosed early clinical results for its KRAS G12D inhibitor, which is being evaluated in more than 200 patients with advanced solid tumors, including metastatic pancreatic ductal…
    STAT · 25d agoPositive readoutPositive↗ source
  • Advocates race to shape rules for AI sandboxes in health care
    The STAT Health Tech newsletter notes that AI sandboxes are becoming a popular mechanism for testing health‑care artificial intelligence under controlled conditions. A broad coalition of industry…
    STAT · 25d agoRegulatoryNeutral↗ source
  • Experts call for Congress to create a dedicated regulatory framework for AI models used in academic medical centers
    On Oct. 15, 2026, several health policy experts voiced support for a new regulatory approach specifically aimed at clinical artificial‑intelligence models that are developed and deployed in academi…
    raps · 26d agoRegulatoryNeutral↗ source
  • U.S. Health Officials Push Policy to Let Specialty Pharmacies Make Certain Peptide Injections
    The Department of Health and Human Services has submitted an interim access policy for peptides to the White House, where it will be reviewed by the Office of Management and Budget. The proposal w…
    STAT · 25d agoRegulatoryNeutral↗ source
  • Personal tragedy highlights deeper flaws in nursing workforce and training gaps
    Lynne S. Moronski, a nurse researcher at the University of Pennsylvania, recounts the loss of her 21‑year‑old daughter, who died after a medication error by direct support professionals in a New Je…
    STAT · 26d agoNegative↗ source
  • Patients struggle to opt out of MyChart data sharing, facing notary and endless hurdles
    An opinion piece highlights how MyChart users who want to stop sharing their health information encounter a maze of requirements. The author describes needing a notary, multiple phone calls, unansw…
    STAT · 26d agoNegative↗ source
  • Around 40% of U.S. high schoolers report binge‑eating in past month, new CDC data shows
    A recent CDC Youth Risk Behavior Survey found that roughly four in ten high school students said they had engaged in binge‑eating during the previous month, marking the first time the biennial surv…
    STAT · 26d agoNegative↗ source
  • FDA launches rare disease framework initiative
    A new initiative from the US Food and Drug Administration (FDA) aims to develop “an optimized, fit-for-purpose” framework to facilitate the development and marketing of treatments for rare diseases…
    raps · 26d ago↗ source
  • FDA expands Anktiva use for BCG-unresponsive high-grade papillary bladder cancer
    The U.S. Food and Drug Administration has broadened the approved use of Anktiva, a therapy given with Bacillus Calmette-Guérin, to treat adults with high-grade papillary-only bladder cancer that ha…
    fda press · 26d agoApprovalPositive↗ source
  • Whoop joins Medicare ACCESS program to offer free wearables and support to seniors
    Whoop, known for fitness wearables aimed at athletes, has been accepted into Medicare’s ACCESS pilot, allowing the company to provide its device and a year‑long subscription to eligible Medicare be…
    STAT · 26d agoPositive↗ source
  • FDA launches Rare Disease Framework Initiative to reshape drug development for small patient populations
    The FDA announced a new Rare Disease Framework Initiative aimed at overhauling how drugs and biologics for rare conditions are developed. The initiative will produce a tailored framework that refl…
    fda press · 26d agoRegulatoryPositive↗ source
  • Study finds almost 40% of FDA advisory committee meetings in past two decades included members with active industry ties
    Researchers examined FDA advisory committee meetings spanning the last 20 years and discovered that nearly 40% of those sessions featured a patient or consumer representative who had active ties to…
    STAT · 26d agoRegulatoryNeutral↗ source
  • FTC and states seek contempt order against Martin Shkreli for breaching pharma work ban
    The U.S. Federal Trade Commission, joined by seven states, asked a federal court to hold former biotech executive Martin Shkreli in contempt. The request cites repeated violations of a court order…
    STAT · 26d agoRegulatoryNegative↗ source
  • States could counter potential Trump administration vaccine shortages by producing vaccines themselves
    Joel Dodge, director of industrial policy at Vanderbilt Policy Accelerator, warns that the Trump administration is considering changes to the Vaccine Injury Compensation Program, a policy that has…
    STAT · 27d agoRegulatoryNegative↗ source
  • UK regulator MHRA unveils multi-year plan to speed AI-driven drug oversight
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released a multi-year strategy aimed at keeping its regulatory framework patient-focused as artificial intelligence and persona…
    raps · 27d agoRegulatoryNeutral↗ source
  • Former FDA leaders denounce agency layoffs as historic disaster
    Three former Food and Drug Administration commissioners publicly condemned the recent staffing reductions at the agency, calling the moves a major failure of policy. Rob Califf, who served as FDA…
    STAT · 26d agoLayoffsNegative↗ source
  • Trump administration delays rule that could curb imported prescription drugs
    The Trump administration announced a 90‑day postponement of a federal rule that would have limited Americans’ ability to purchase prescription medicines from licensed pharmacies abroad. The rule w…
    STAT · 26d agoRegulatoryPositive↗ source
  • Sanofi avoids fine as EU ends antitrust probe over alleged disparagement of rival flu vaccine
    EU antitrust regulators have closed a probe into Sanofi after the company offered concessions, allowing it to avoid a monetary penalty. The investigation centered on a campaign that allegedly port…
    STAT · 26d agoRegulatoryNeutral↗ source
  • Doctors, hospitals and insurers lobby states on medical AI regulation
    A coalition of lobbying groups representing physicians, hospitals, a health insurer and AI firms met in Washington to craft guidance for state regulation of medical AI. The group, organized by the…
    STAT · 27d agoRegulatoryNeutral↗ source