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2,336 stories matching this filter · ← front page

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  • Eli Lilly expands early-access program for experimental obesity drug retatrutide
    Eli Lilly announced it will broaden its early-access initiative for retatrutide, an investigational drug targeting obesity. The company said the program will let additional patients apply for the…
    STAT · 3mo agoRegulatoryPositive↗ source
  • Aurora Therapeutics halts its custom CRISPR program and cuts staff after competitor Beam moves ahead
    Aurora Therapeutics, a startup developing personalized gene-editing drugs, announced it is abandoning its lead CRISPR program. The decision came just seven months after the company launched, and i…
    STAT · 3mo agoLayoffsNegative↗ source
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  • Lilly expands access to its experimental obesity therapy while Jazz pulls Zepzelca's second-line lung cancer use
    Lilly announced it will broaden the expanded‑access program for its obesity drug that has not yet received regulatory approval, allowing more patients to receive the treatment under a compassionate…
    raps · 3mo agoRegulatoryNeutral↗ source
  • FDA invites stakeholder input to shape a new Quantitative Medicine Innovation Network
    The FDA announced it is looking for feedback from a broad range of stakeholders to help design a Quantitative Medicine Innovation Network (QMIN). The proposed QMIN would be a cross-sector platform…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Two Michigan Cyclospora Deaths Reported as Eli Lilly Expands Special Retatrutide Access
    Two people in Michigan have died after contracting cyclospora, a parasitic infection that is rarely fatal but can be severe for those with underlying health conditions. State health officials confi…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Patient finds open-source diabetes app improves control despite lack of FDA approval
    Patient has type 1 diabetes for over 30 years and has used FDA-approved pumps and sensors that were upgraded roughly every five years. Over time his glucose control slipped despite the regulated de…
    STAT · 3mo agoPositive↗ source
  • Experts debate extra regulation for low-risk digital wellness devices
    Two recent papers published in JAMA have highlighted concerns about low-risk digital health technologies that consumers use. Experts say that even though these tools are considered low-risk, they…
    raps · 3mo agoRegulatoryNeutral↗ source
  • New York study questions effectiveness of involuntary outpatient mental health treatment, urges more funding for voluntary services
    A new evaluation of New York's involuntary outpatient treatment program adds to a growing body of research on court‑ordered mental health care. The study examined outcomes for people with serious c…
    STAT · 3mo agoNegative↗ source
  • Blank Slate Creamery recalls vegan coconut fudge sandwiches over undeclared egg allergen
    Blank Slate Creamery of Ann Arbor, Michigan announced a recall of its 4.5‑ounce vegan non‑dairy frozen dessert coconut fudge sandwiches because the product may contain egg, an undeclared allergen.…
    fda recalls · 3mo agoCRLNegative↗ source
  • Physician reflects on Quebec's assisted-suicide landscape through Josée Lamère’s story
    Sai Rajagopal, a Canadian physician and researcher, writes an opinion piece that follows the life of Josée Lamère, who became one of the 7.9 percent of Quebecers who have chosen assisted suicide. H…
    STAT · 3mo agoNeutral↗ source
  • California Supreme Court rejects claim that Gilead must fast-track safer HIV drug
    Thousands of patients sued Gilead Sciences, alleging the company was negligent for delaying a safer HIV medicine and that they suffered kidney injury and bone loss from the older drug. The Califor…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Medicare to End Extra Payments for FDA Breakthrough Devices Starting FY2028
    Medicare announced that it will eliminate the special pathways that have let medical devices labeled as breakthrough by the FDA receive supplemental payments without showing a clear clinical advant…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Sandoz to Pay $478.5 Million to Settle Generic Drug Price-Fixing Claims
    Sandoz has agreed to pay $478.5 million to resolve allegations that it participated in a widespread conspiracy to inflate and manipulate the prices of generic medicines. Dozens of U.S. states and i…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Eli Lilly’s one-patient early access to retatrutide leaves doctors seeking answers
    Eli Lilly granted a single 79-year-old patient special access to retatrutide, an experimental obesity drug that has shown weight‑loss results comparable to bariatric surgery. Since that decision,…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Moderna awaits FDA decision on mRNA flu vaccine as biotech fund launches and pricing disputes intensify
    Moderna is awaiting the FDA's decision on its mRNA influenza vaccine, which could become the first seasonal flu shot using messenger RNA technology. Meanwhile, venture firm TCGX announced a new $4…
    STAT · 3mo agoNeutral↗ source
  • AstraZeneca shares drop 5.5% as investors react to reported merger talks with Bristol Myers Squibb
    AstraZeneca's share price slipped on Monday after Reuters reported that the company is in merger talks with Bristol Myers Squibb. The potential combination would create a drugmaker valued at rough…
    STAT · 3mo agoDealNegative↗ source
  • BioNTech appoints Guido Oelkers as new CEO, succeeding cofounder Ugur Sahin
    BioNTech announced that Guido Oelkers will become its chief executive officer, taking over from cofounder Ugur Sahin. Oelkers comes from Swedish biopharma Sobi, where he led the company, and bring…
    STAT · 3mo agoNeutral↗ source
  • In-patient cardiac pre-hab program launched to keep heart-transplant candidates fit while awaiting surgery
    Patients waiting in the hospital for a heart transplant often lose strength and can become ineligible for the procedure as their fitness declines. To address this, Dr. Radha Gopalan at Banner‑Univ…
    STAT · 3mo agoPositive↗ source
  • FDA releases new guidances on adhesive performance and skin irritation studies for transdermal generic drugs
    The U.S. Food and Drug Administration has issued two new guidances that address transdermal or topical delivery systems for generic drugs. One is a final guidance that outlines how to assess adhesi…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Michigan reports first two U.S. deaths linked to cyclospora outbreak
    State health officials said two people died in Michigan, marking the first confirmed U.S. deaths from cyclospora, a microscopic parasite. Both victims had pre‑existing health conditions that may h…
    STAT · 3mo agoNegative↗ source
  • TGA seeks industry input on adopting 11 international scientific guidelines in Australia
    The Therapeutic Goods Administration announced it will consider incorporating eleven internationally recognised scientific guidelines into the Australian regulatory framework. The agency has opene…
    raps · 3mo agoRegulatoryNeutral↗ source
  • FDA issues new guidances on adhesive performance and skin irritation testing for generic transdermal drugs
    The U.S. Food and Drug Administration has released two new guidances that address transdermal and topical delivery systems for generic drugs. One guidance, issued as final, focuses on how manufact…
    raps · 3mo agoRegulatoryNeutral↗ source
  • FSMB leaders say AI not ready for independent medical licensing
    The Federation of State Medical Boards issued an opinion that artificial‑intelligence tools are not yet suitable for independent medical licensure. The board argues that a medical license is more…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Medical schools debate AI scribes as teaching tools versus learning crutches
    Hospitals have rapidly adopted AI-powered note-taking tools, saying they reduce physician burnout and boost revenue. Medical schools, however, are cautious. While they want graduates to be comfort…
    STAT · 3mo agoNeutral↗ source
  • FDA releases new guidances on adhesives and skin irritation testing for transdermal drug products
    The U.S. Food and Drug Administration has issued two new guidances that focus on transdermal and topical delivery systems used for generic medicines. One guidance, finalized, provides recommendati…
    raps · 3mo agoRegulatoryNeutral↗ source