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40 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 · 8h 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 · 8h agoApprovalPositive↗ source
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73
fda recalls47
fda medwatch38
fda press28
899
Psychiatry & CNS712
Ophthalmology421
Endocrinology & Metabolism382
Pain375
Infectious Disease356
  • 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 · 13h agoRegulatoryNegative↗ 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
  • 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
  • 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 · 17d 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
  • Argon Medical issues correction for convenience kits containing lidocaine ampules after FDA safety alert
    Argon Medical has sent a correction notice to customers about certain convenience kits that include lidocaine HCl ampules supplied by Spectra Medical Devices. The FDA has classified this correctio…
    fda medwatch · 21d agoCRLNegative↗ 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
  • 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
  • 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
  • Opinion: Hospitals are silencing doctors online, and it’s fueling the health misinformation crisis
    Hospitals and health systems need to loosen the reins and let physicians combat social media misinformation, writes Adam Goodcoff.
    STAT · 3mo ago↗ source
  • Safety and Toxicity Management in Metastatic Castration-Resistant Prostate Cancer
    Dr. Johann De Bono and Dr. Pedro Barata discuss practical approaches to monitoring and managing toxicities associated with radiopharmaceutical therapies in metastatic castration-resistant prostate…
    onclive · 3mo ago↗ source
  • Combination and Sequencing Strategies in Metastatic Castration-Resistant Prostate Cancer
    Dr. Pedro Barata and Dr. Johann De Bono discuss ongoing questions surrounding combination approaches and optimal sequencing strategies for radiopharmaceutical therapies in metastatic castration-res…
    onclive · 3mo ago↗ source
  • Patient Selection for Radiopharmaceuticals in Metastatic Castration-Resistant Prostate Cancer
    Dr. Pedro Barata and Dr. Johann De Bono discuss how patient selection and disease characteristics influence the use of radiopharmaceuticals in metastatic castration-resistant prostate cancer (mCRPC).
    onclive · 3mo ago↗ source