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  • WHO publishes first interim list of medical device authorities; AstraZeneca explores AI to reduce late-stage risk
    The World Health Organization has issued its first interim list of medical device authorities, marking a step toward greater transparency in device regulation. The list is intended to guide manufac…
    raps · 3mo agoRegulatoryNeutral↗ source
  • EMA commits to safeguarding stakeholder data; FDA advisory panel expands compounding peptide list
    The European Medicines Agency announced that it will assume ultimate responsibility for protecting information submitted by stakeholders through online meeting registrations and surveys, in line wi…
    raps · 3mo agoRegulatoryNeutral↗ source
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  • FDA issues three new guidances to expand eligibility criteria for cancer trials
    The FDA's Oncology Center of Excellence has released three final guidance documents aimed at widening the pool of patients who can enroll in oncology clinical trials. The guidances focus on three…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Sarepta Therapeutics appoints Michael Severino, former Tessera CEO, as new chief executive
    Sarepta Therapeutics announced that Michael Severino will become its chief executive, effective Tuesday. Severino previously led Tessera Therapeutics. He replaces Doug Ingram, who said he will ret…
    STAT · 3mo agoNeutral↗ source
  • Study shows drug development and reimbursement timelines align across four major markets
    Researchers published a cross‑sectional analysis in JAMA Health Forum examining how long it takes for a drug to move from the start of clinical trials to receiving reimbursement approval. The anal…
    raps · 3mo agoNeutral↗ source
  • FDA panel backs compounding pharmacies to make two peptides, rejects third
    The U.S. Food and Drug Administration’s advisory committee met on Friday and issued recommendations on the manufacturing of certain peptide drugs by compounding pharmacies. Committee members voted…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Australia's TGA adopts 23 international scientific guidelines from EMA, ICH and FDA
    The Therapeutic Goods Administration (TGA) in Australia announced it has formally adopted 23 scientific guidelines. The guidelines come from the European Medicines Agency, the International Counci…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Medical schools add hands-on nutrition programs while avoiding broader HHS priorities
    When students return to McGovern Medical School at UT Health Houston, they will take part in hands‑on nutrition experiences such as cooking demonstrations, tours of a holistic garden, and a culinar…
    STAT · 3mo agoNeutral↗ source
  • E‑bikes and e‑scooters driving surge in severe pediatric injuries, say pediatric surgeons
    J. Todd R. Lawrence, a pediatric orthopedic surgeon, and Madison A. Kesler, a research associate at Children’s Hospital of Philadelphia, note a rapid rise in serious injuries among children using e…
    STAT · 3mo agoNegative↗ source
  • Midwives urge role in combating medical misinformation as patients reject blood based on vaccine myths
    Midwife Mara Evans, based in North Carolina and faculty at Georgetown University’s Berkley School of Nursing, writes about her experience in a Nevada delivery room. She describes the careful handli…
    STAT · 3mo agoNeutral↗ source
  • Merck grants royalty-free licenses for experimental HIV prevention pill to generic makers in 129 low-income countries
    Merck announced voluntary licensing agreements that let generic manufacturers produce its experimental HIV prevention pill, known as alimatravir, in low- and middle-income markets. The deals cover…
    STAT · 3mo agoDealPositive↗ source
  • FDA panel backs compounding of epitalon, rejects emideltide in narrow vote
    The FDA advisory committee voted to allow compounding pharmacies to produce the peptide epitalon, while narrowly voting against allowing the production of emideltide. The decision follows the pane…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Fatal gene-editing trial in China sparks ethics and oversight concerns
    A six-year-old girl in China died after receiving an experimental brain-directed CRISPR therapy, according to a report in Science. The tragedy has intensified calls for stronger ethical review and…
    STAT · 3mo agoRegulatoryNegative↗ source
  • FDA panel backs compounding pharmacies to produce four peptide drugs, amid insulin pen shortage and Merck HIV pill license
    An FDA advisory committee voted to allow compounding pharmacies to prepare four peptide-based medicines, a decision hailed by supporters of peptide therapeutics. The briefing also mentioned that M…
    STAT · 3mo agoRegulatoryPositive↗ source
  • U.S. drug shortages stem from weak regulation, not China competition, says expert
    In 2025 the United States faced 216 active drug shortages, limiting access to lifesaving medicines for patients. While the White House and national‑security officials have framed the problem as a…
    STAT · 3mo agoRegulatoryNegative↗ source
  • White House science blueprint pushes billions toward AI firms, away from university life-science research
    The White House Office of Science and Technology Policy released a report titled “Science: A New Golden Age.” The document outlines a new direction for U.S. federal science funding. The plan calls…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Baxter recalls cefazolin injection after cardboard particles detected
    Baxter International announced a voluntary nationwide recall of lot LD175708 of its cefazolin in dextrose injection, a single‑dose 100 ml infusion bag. The recall was prompted by a report that car…
    fda recalls · 3mo agoCRLNegative↗ source
  • FDA issues early alert on Boston Scientific ENROUTE catheter tip separation risk
    The CDRH has issued an Early Alert warning about a potential high risk issue with Boston Scientific's ENROUTE Transcarotid Neuroprotection System and its Plus version. The problem involves possibl…
    fda medwatch · 3mo agoCRLNegative↗ source
  • Sunny Pharmtech voluntarily recalls three lots of cyclophosphamide injection after steel particles found
    Sunny Pharmtech, Inc. announced a voluntary nationwide recall of three lots of cyclophosphamide for injection, USP, in 1‑gram and 2‑gram vials. The recall was triggered by the detection of steel pa…
    fda medwatch · 3mo agoCRLNeutral↗ source
  • FDA advisory panel recommends adding peptides BPC-157 and KPV to bulk compounding list
    An FDA advisory committee voted 8-6, with one abstention, to recommend that two experimental peptides – BPC-157 for ulcerative colitis and KPV for wound and inflammatory conditions – be placed on t…
    raps · 3mo agoRegulatoryNeutral↗ source
  • FDA advisory panel adds six peptides to compounding bulk drug list, rejects one
    The FDA’s advisory committee concluded a two-day meeting on Friday, reviewing seven peptide drug substances for inclusion on the agency’s bulk-drug compounding list. Committee members voted to add…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Senate moves forward bill to require warning labels on ultra-processed foods and ban child-targeted junk-food ads
    The Senate Health, Education, Labor and Pensions Committee voted to advance a bill that would require the FDA to place prominent warning labels on ultra-processed foods high in sugar, salt or satur…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Baxter voluntarily recalls Cefazolin in Dextrose injection after cardboard particles found
    Baxter International announced a voluntary nationwide recall of Lot LD175708 of its Cefazolin in Dextrose Injection, a single-dose infusion bag. The recall follows a report that cardboard particle…
    fda recalls · 3mo agoCRLNegative↗ source
  • FDA advisory panel backs compounding pharmacies to produce four popular peptides, defying prior committee advice
    The Food and Drug Administration’s advisory panel voted to allow compounding pharmacies to manufacture four peptide drugs that have gained popularity among health‑seeking individuals. The recommend…
    STAT · 3mo agoRegulatoryPositive↗ source
  • U.S. measles cases in 2026 already exceed total from record-breaking 2025 year
    The CDC reports 2,318 measles cases in the United States so far in 2026, surpassing the 2,289 cases recorded for the entire year of 2025. The increase makes 2026 the worst measles year since 1991,…
    STAT · 3mo agoNeutral↗ source