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23 stories matching this filter · ← front page

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  • 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 · 13h agoRegulatoryNeutral↗ 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 · 14h agoRegulatoryNegative↗ source
28
fda recalls22
fda press21
fda medwatch17
178
Vaccines163
Pain106
Ophthalmology103
Endocrinology & Metabolism94
Nephrology71
  • 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 · 19h ago↗ 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 · 1d agoPositive readoutPositive↗ 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 · 1d agoPositive↗ source
  • After PCOS became PMOS, there’s hope for new awareness among Black and Latina women
    Growing awareness of a painful endocrine disorder now named PMOS is good news for women of color, who have high prevalence and low diagnosis.
    STAT · 2d 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 · 3d agoRegulatoryNeutral↗ source
  • This Week at FDA: Diamantas touts onshoring efforts, grants for DHTs, and more
    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This we…
    raps · 6d ago↗ source
  • FDA advisory committee backs two more peptides, rejects one for compounding list
    By the end of a two-day meeting that concluded Friday afternoon, an advisory committee to the US Food and Drug Administration (FDA) voted in favor of adding six of the seven peptides it was tasked…
    raps · 6d ago↗ source
  • FDA panel confronting peptide controversy
    Today's biotech news features the FDA weighing the fate of peptides; approvals for RevMed, GSK; and data on Lilly's "triple-G."
    STAT · 7d ago↗ source
  • Trump administration says it’s deferring $1B in Medicaid payments to California and Minnesota
    The Trump administration said it was deferring more than $1 billion in Medicaid payments to Minnesota and California because of “suspected fraud and noncompliance.”
    STAT · 9d ago↗ source
  • STAT+: The next step of site-neutral, and a fiery PBM hearing
    Medicare proposes to reduce payments to hospitals for certain drugs and imaging services.
    STAT · 10d ago↗ source
  • Opinion: STAT readers on the value of primary care, obesity as a disease, and more
    “The real opportunity is to move beyond policies and narratives that pit specialties against one another,” presidents of the AAFP, ACP, and AAP write.
    STAT · 12d ago↗ source
  • Updated: BlossomHill and Latigo join flourishing IPO queue with cancer, pain drugs
    Last summer, zero biotechs made it onto the public markets as the industry weathered a seven-month dry spell for initial share sales. This time around, it's a summer IPO party as six
    Endpoints · 13d ago↗ source
  • Who can access testosterone hormone medication in the U.S.?
    Wildfire smoke health hazards, a new idea for treating Duchenne, and more health news from Morning Rounds
    STAT · 13d ago↗ source
  • STAT+: Despite earnings celebration, UnitedHealth signals more financial pain for employers
    Insurance giant UnitedHealth signals the cost of providing workers with health insurance will climb even higher.
    STAT · 14d ago↗ source
  • Opinion: The growing fang-to-pharmacy pipeline
    “Some of the most powerful medicines we will ever find are already here, carried in the fangs, stingers, and saliva of creatures we’ve been taught to fear,” writes Steve Midway.
    STAT · 14d ago↗ source
  • Convenience Kit Recall: B. Braun Medical, Inc. Removes Spinal Anesthesia Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP
    B. Braun is removing affected convenience kits containing recalled Bupivacaine Hydrochloride in Dextrose Injection components
    fda medwatch · 14d ago↗ source
  • Convenience Kit Correction: Arrow International Issues Correction for Convenience Kits Containing Recalled Huons Lidocaine and Bupivacaine and Saline
    Saline, Lidocaine and Bupivacaine from affected convenience kits should not be used.
    fda medwatch · 14d ago↗ source
  • STAT+: Swing Therapeutics acquired by medical VR platform XR Health
    Swing Therapeutics, developer of a digital treatment for fibromyalgia, has been acquired by medical virtual reality company XR Health.
    STAT · 15d ago↗ source
  • As states absorb Medicaid funding cuts, family caregivers face financial ruin
    Family caregivers of people with disabilities face a grim financial future as several states consider steep cuts to their wages.
    STAT · 17d ago↗ source
  • STAT+: How a Boston doctor built a following as a ‘loud and unafraid’ voice in the Trump era
    Jeremy Faust saves lives in the ER and breaks stories with his Inside Medicine newsletter. He’s also testing the bounds of news reporting.
    STAT · 20d ago↗ source
  • Opinion: Your grandparents are using cannabis. Doctors can help them do it safely
    Over the past 25 years, I have treated thousands of medical cannabis patients with extremely few ill effects, one doctor writes.
    STAT · 21d ago↗ source