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44 stories matching this filter · ← front page

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  • Regeneron’s ultra-rare bone disorder drug receives U.S. approval after 30-year development
    Regeneron Pharmaceuticals announced that its therapy for an ultra-rare condition in which bone forms in soft tissue has been approved by the U.S. Food and Drug Administration. The disease, sometim…
    STAT · 5h agoApprovalPositive↗ source
  • FDA approves Ultragenyx gene therapy and Regeneron ultra-rare disease drug
    The Food and Drug Administration gave the green light to a gene‑therapy product from Ultragenyx, marking a new treatment option in the company’s pipeline. In a separate decision, Regeneron secured…
    STAT · 4h agoApprovalPositive↗ source
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73
fda recalls47
fda medwatch37
fda press28
899
Psychiatry & CNS712
Ophthalmology421
Endocrinology & Metabolism380
Pain373
Infectious Disease353
  • Capricor’s Duchenne drug deramiocel receives negative FDA advisory vote on heart outcome
    Mindy Leffler, a parent of a young man with Duchenne muscular dystrophy, writes an opinion piece about Capricor’s phase 3 study of its drug deramiocel. She describes her son’s experience living ind…
    STAT · 9h agoRegulatoryNegative↗ source
  • FDA approves Regeneron’s garetosmab for ultra-rare bone-forming disease
    The FDA has granted approval to Regeneron's antibody garetosmab, which targets activin A, for the treatment of fibrodysplasia ossificans progressiva (FOP). FOP is an ultra‑rare disorder that causes…
    Endpoints · 23h agoApprovalPositive↗ source
  • Merck and Moderna report success in late-stage trial of personalized mRNA cancer vaccine
    Merck and Moderna announced that their personalized mRNA cancer vaccine achieved its primary endpoint in a randomized late-stage trial, marking the first demonstration that such an approach can be…
    STAT · 1d agoPositive readoutPositive↗ source
  • Regeneron's Pasatru receives FDA approval for ultra-rare bone-growth disease FOP
    Regeneron Pharmaceuticals has secured FDA approval for Pasatru, a therapy aimed at treating fibrodysplasia ossificans progressiva (FOP), an ultra‑rare condition in which bone forms in soft tissues.…
    STAT · 1d agoApprovalPositive↗ source
  • BioMarin signs new deal for early-stage bone disease asset
    BioMarin recently halted development of a rare disease drug that it had acquired in a $270 million transaction. Within a week, the company announced another deal to acquire an early‑stage asset aim…
    Endpoints · 2d agoDealNeutral↗ source
  • Safety concerns emerge as radiopharmaceuticals advance in cancer trials
    Radiopharmaceuticals are being hailed for their ability to deliver radiation directly to tumours, potentially sparing surrounding healthy tissue and improving cancer therapy. However, as more cand…
    STAT · 10d agoNegative↗ source
  • Call to unify MD and DO medical education pathways
    Physicians Abigail MacKenzie and Vijay Rajput argue that keeping medical education split between allopathic (MD) and osteopathic (DO) tracks is an outdated practice that adds no value to patient ca…
    STAT · 15d agoPositive↗ source
  • Hinge Health to acquire Cylinder Health for $105 million, expanding into digestive care
    Hinge Health, known for virtual physical therapy, announced it will purchase digestive health startup Cylinder Health. The transaction is a cash deal valued at $105 million, marking Hinge's latest…
    Endpoints · 15d agoDealPositive↗ 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 · 16d agoRegulatoryNeutral↗ 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 · 21d agoNeutral↗ source
  • A decade after WHO recognition, mycetoma is still one of the world’s most neglected diseases
    Borna Nyaoke-Anoke, a physician leading mycetoma work at the Drugs for Neglected Diseases initiative, reflects on a decade since the World Health Organization formally acknowledged the disease. Sh…
    STAT · 21d agoNegative↗ source
  • Study finds rising job dissatisfaction and health‑care access uncertainty among U.S. workers
    A new study shows increasing levels of job dissatisfaction and uncertainty about health‑care access among U.S. workers. The research, funded by AHRQ, surveyed a national sample and found that a gr…
    STAT · 29d agoNegative↗ source
  • Urologist warns that Defense Dept's testosterone screening for servicemembers fuels outdated masculinity myths
    Dr. Elizabeth Dray, a urologist, criticizes Defense Secretary Pete Hegseth's recent plan to screen all service members aged 30 and older for testosterone, describing it as a modern echo of ancient…
    STAT · 1mo agoNegative↗ source
  • Nava Therapeutics raises $89 million to advance lipid nanoparticle platform targeting bone marrow, immune cells and kidney
    Nava Therapeutics, a stealth-mode biotech, announced it has secured $89 million in financing, according to a statement to Endpoints News. The capital will support development of a next generation…
    Endpoints · 1mo agoDealPositive↗ source
  • Roche stops two Huntington's disease gene-silencing programs after disappointing trial data
    Roche announced it is ending development of two gene‑silencing candidates aimed at Huntington's disease after data failed to meet expectations. The decision follows a recent readout that showed in…
    STAT · 1mo agoNegative↗ source
  • Statins and blood pressure drugs changing health risks of obesity, study suggests
    New research shows obesity patients over 40 are managing blood pressure and cholesterol as well as healthy-weight peers, but younger adults remain at risk.
    STAT · 1mo ago↗ source
  • Opinion: Short-sighted new student loan caps elevate chiropractic care over critical health care professions
    “This administrative logic is hopelessly out of touch with the empirical reality of American health care,” writes David S. Shapiro.
    STAT · 1mo ago↗ source
  • Biotech SPAC deal gets it to Nasdaq; AstraZeneca Phase 3 win in bone disease
    Plus news about Alebund Pharmaceuticals, Regenxbio and Neuphoria Therapeutics. 💸 A SPAC!: Talawar Therapeutics will land on the Nasdaq via a combination with blank-check company JATT II Acquisitio…
    Endpoints · 1mo ago↗ source
  • STAT+: Where ‘democracy met science,’ 50 years ago
    State Medicaid crackdowns strain home care, WHO leader on Ebola outbreak, and more health news
    STAT · 2mo ago↗ source
  • STAT+: Amid confusion over Pfizer’s emergency penicillin program, newborn is diagnosed with preventable syphilis
    Congenital syphilis should be preventable. An Arizona case shows how drug shortages and procedural hurdles are fueling a growing public health crisis.
    STAT · 2mo ago↗ source
  • When it’s time to save a limb, novel clinic meets unhoused people where they are
    Unmet vascular needs can lead to limb loss among unhoused patients. An unusual Massachusetts General Hospital program meets patients where they are.
    STAT · 2mo ago↗ source
  • Opinion: American horses are obese, too
    “American horses are getting sick in ways that look remarkably familiar,” writes Joshua Moen.
    STAT · 2mo ago↗ source
  • Male puberty is understudied — but when it starts may predict long-term health risks
    Due to a significant gender gap, far less is known about the health risks of early or late puberty onset among boys than girls.
    STAT · 2mo ago↗ source