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  • FDA panel rejects Capricor's Duchenne drug, citing insufficient efficacy data
    The U.S. Food and Drug Administration advisory committee voted 9-to-3 against a Capricor Therapeutics candidate for Duchenne muscular dystrophy. The panel said the clinical data did not provide sub…
    STAT · 5h agoRegulatoryNegative↗ source
  • Ebola cases approach key milestone as vaccine candidates draw near completion
    The latest update on the Ebola outbreak indicates that the number of cases is approaching a significant threshold, while vaccine development efforts are reported to be close to delivering a usable…
    STAT · 7h agoNeutral↗ source
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  • Senate health panel confirms Trump picks for CDC director and pandemic preparedness chief
    The Senate health committee approved two Trump administration nominees for key health positions on Thursday. Erica Schwartz was confirmed as CDC director with bipartisan support from all Republica…
    STAT · 4h agoRegulatoryNeutral↗ source
  • FDA advisory panel reviews Replimune's experimental melanoma therapy RP1
    STAT is live-blogging an FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting that convened on Thursday to examine Replimune's engineered viral immunotherapy RP1 for melanoma. The p…
    STAT · 8h agoRegulatoryNeutral↗ source
  • Opinion: Ten years after WHO recognition, mycetoma remains one of the world’s most neglected diseases
    “The next 10 years of mycetoma care will determine whether it remains a story of neglect or becomes one of collective action,” writes Borna Nyaoke-Anoke.
    STAT · 10h agoRegulatoryNeutral↗ source
  • Experts warn U.S. pharma reliance on China poses national security threat
    The authors of a recent Council on Foreign Relations report argue that the United States’ dependence on China for biopharmaceutical manufacturing creates a clear national security risk. They point…
    STAT · 10h agoNegative↗ source
  • Medicaid work rules spark confusion over medically frail exemption, risking coverage for chronically ill
    Nebraska will begin enforcing Medicaid work requirements next week, demanding that beneficiaries work, volunteer or attend school for at least 80 hours each month or risk losing their health covera…
    STAT · 10h agoRegulatoryNegative↗ source
  • Federal judge rejects 26 states' bid to delay Medicaid work requirement rollout
    A U.S. District Judge in Massachusetts issued an order Thursday refusing to grant a preliminary injunction that would have paused the new Medicaid work‑requirement rules. The decision leaves the fe…
    STAT · 5h agoRegulatoryNeutral↗ source
  • Red Bull-funded studies downplay risks of mixing energy drinks with alcohol, shaping policy despite independent warnings
    An investigative report found that research funded by the energy‑drink maker contradicted the bulk of independent studies on the dangers of combining alcohol with caffeinated beverages. The funded…
    STAT · 14h agoRegulatoryNegative↗ source
  • STAT+: Rising oil prices can boost the cost of some medicines. One expert says it’s time to lower reliance on fossil fuels
    Unitaid found the rising price of oil could boost the cost of a widely used HIV medicine it reviewed in a detailed analysis.
    STAT · 5h ago↗ source
  • Convenience Kit Correction: Argon Medical Issues Correction for Convenience Kits Containing Spectra Medical Device Lidocaine Ampules
    Argon Medical is correcting affected convenience kits by removing included Spectra Medical Devices Lidocaine Ampules.
    fda medwatch · 14h ago↗ source
  • FDA approves first freeze-dried plasma product for U.S. use
    The FDA has licensed Ezplaz Freeze Dried Plasma (FDP), marking the first freeze-dried plasma product cleared for use in the United States. The product is intended for adult patients who need plasm…
    fda press · 1d agoApprovalPositive↗ source
  • Latigo's mid-stage trial shows non-opioid pill LTG-001 cuts post-surgery pain, outperforms placebo
    Latigo Biotherapeutics reported positive Phase 2 data for its experimental oral analgesic LTG-001, tested in patients who had undergone tummy-tuck surgery. The study enrolled 343 participants who w…
    STAT · 21h agoPositive readoutPositive↗ source
  • Trump administration ends Medicare drug plan subsidies, raising cost concerns ahead of midterms
    The White House announced that subsidies for private Medicare prescription drug plans will be discontinued, a move expected to increase premiums for many seniors. The policy shift comes as Democra…
    STAT · 1d agoRegulatoryNegative↗ source
  • Benchmarking Clinical LLMs Proves Complex After Recent Nature Medicine Study
    The STAT AI Prognosis newsletter, written by health‑tech reporter Brittany Trang, looks at why evaluating new clinical large language models is difficult. A recent Nature Medicine paper compared s…
    STAT · 1d agoNeutral↗ source
  • Former VA Secretary argues the Veterans Health Administration can boost US biotech competitiveness against China
    The piece, authored by former Veterans Affairs Secretary David Shulkin, positions the VA as a critical component of America’s biotechnology ecosystem alongside HHS and the Department of Defense. H…
    STAT · 1d agoNeutral↗ source
  • Study finds clinical chatbots lag behind general AI models in accuracy, sparking debate among doctors
    Hundreds of thousands of U.S. physicians are using clinical large language model tools marketed by firms such as OpenEvidence, Doximity and UpToDate as safer alternatives to generic AI chatbots. A…
    STAT · 1d agoNegative readoutNegative↗ source
  • FTC sues Hims & Hers for misleading consumers and privacy violations
    The Federal Trade Commission, joined by Utah and California, filed a lawsuit against Hims & Hers, a direct-to-consumer telehealth provider, alleging deceptive business practices. The complaint say…
    STAT · 1d agoRegulatoryNegative↗ source
  • Fugitive Discovered Working Under Alias in Biotech Industry Amid Legal Battles Involving AstraZeneca and Lilly
    A Rhode Island fugitive who had been on the most-wanted list was recently uncovered as having worked under a false identity in the biotech sector. The revelation raised questions about how the ind…
    STAT · 1d agoNegative↗ source
  • STAT+: FDA expert panel recommends against approval of Capricor’s Duchenne drug
    STAT is live-blogging an FDA meeting on Capricor Therapeutics’ treatment for Duchenne muscular dystrophy, which has been the subject of a contentious regulatory review.
    STAT · 1d agoRegulatoryNeutral↗ source
  • NSF launches $47 million pilot to create joint university-industry Ph.D. programs for life scientists
    The National Science Foundation, with funding announced by the Trump administration, is testing a new Ph.D. training model that blends academic study with industry experience. The $47 million pilo…
    STAT · 21h agoPositive↗ source
  • Prolonged hospital stays leave children isolated, urging change
    An author visiting a pediatric ward describes a young, nonverbal child with severe developmental delays who has been waiting months for a life-saving liver transplant. The child lies in a stark, ma…
    STAT · 1d agoNegative↗ source
  • Most-wanted fugitive Ronald Fischer operated under alias in biotech industry for two decades
    A Rhode Island man on the most-wanted list was recently uncovered as a hidden employee in the biotech sector, having worked under a false identity for about twenty years. The individual, identifie…
    STAT · 1d agoNegative↗ source
  • Fauci invokes Fifth Amendment, declines to answer Covid-19 origins questions at Senate hearing
    At a Senate hearing on Wednesday, former U.S. health chief Anthony Fauci invoked his Fifth Amendment right and refused to answer lawmakers' questions about the Covid-19 pandemic and its origins. F…
    STAT · 1d agoRegulatoryNeutral↗ source
  • Morning Rounds flags overlooked pedestrian and cyclist deaths, upcoming Fauci Senate hearing, and research visa limits
    The latest Morning Rounds newsletter draws attention to the often‑ignored problem of deaths among pedestrians and cyclists, urging greater public health focus. It also notes that Dr. Anthony Fauci…
    STAT · 1d agoNeutral↗ source