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55 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
  • Oxford study offers model showing statins pose minimal muscle disorder risk, a tool against health misinformation
    The piece highlights how fearmongering about statins has surged online, with claims that the drugs damage the brain, liver and muscles. The authors argue that clearer evidence at the point of claim…
    STAT · 7d agoPositive↗ source
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fda recalls47
fda medwatch38
fda press28
899
Psychiatry & CNS712
Ophthalmology421
Endocrinology & Metabolism382
Pain375
Infectious Disease356
  • 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
  • FDA approves first mRNA seasonal flu vaccine, mFlusiva, a year after funding cuts
    The U.S. Food and Drug Administration granted approval to mFlusiva, the first mRNA‑based seasonal influenza vaccine, after its advisory committee voted unanimously that the benefits outweigh the ri…
    STAT · 14d agoApprovalPositive↗ source
  • Opinion: Limb girdle muscular dystrophy patients face a maddening reality
    “Too often, regulatory tools authorized to speed patient access to breakthrough treatments are being used in ways that even prevent approval,” writes Kat Bryant Knudson.
    STAT · 20d agoRegulatoryNeutral↗ 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 · 22d agoNegative↗ source
  • FDA finds Capricor's Duchenne stem cell therapy failed to meet Phase 3 goals, contradicting company claims
    The U.S. Food and Drug Administration announced that the stem cell treatment from Capricor Therapeutics did not achieve the primary objectives in its Phase 3 trial for Duchenne muscular dystrophy.…
    STAT · 23d agoRegulatoryNegative↗ source
  • GSK CEO outlines £1.9bn cost-saving drive and aims to launch 20 Phase 3 trials by year-end
    GSK chief executive Luke Miels presented a three‑year plan to make the company more agile and generate significant cost efficiencies. The strategy targets £1.9 billion in annual savings by 2029, wi…
    STAT · 23d agoPositive↗ source
  • Biotech firms rush to develop gene-editing cure for rare alpha-1 antitrypsin deficiency
    A wave of biotech companies is intensifying efforts to cure alpha-1 antitrypsin deficiency (AATD), a rare liver and lung disorder, using gene-editing approaches. Companies such as Beam, Wave Life…
    STAT · 23d agoNeutral↗ source
  • CDC survey shows racial gaps in diagnosis of endometriosis, PMOS and uterine fibroids among US women
    A recent CDC National Center for Health Statistics report based on a 2022-2023 survey of about 5,000 women ages 20 to 49 provides new insight into how often certain gynecologic conditions are diagn…
    STAT · 23d agoNeutral↗ source
  • Defense Secretary proposes annual testosterone screening for service members, sparking mixed expert reaction
    U.S. Defense Secretary Pete Hegseth announced that service members will have testosterone deficiency testing added to their annual physical exams. The plan targets war-fighters aged 30 and older, w…
    STAT · 1mo agoNeutral↗ source
  • Senator Cassidy challenges Trump pandemic nominee over anti-vaccine LinkedIn post
    Senate Health Committee Chairman Bill Cassidy confronted Sean Kaufman, President Trump's nominee for a senior pandemic preparedness position, during the confirmation hearing. Cassidy cited a delet…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Former FDA toxicologist says agency approved Zyn nicotine pouches without fully knowing their composition
    Former FDA toxicologist Christy Leppanen alleges the agency authorized Zyn nicotine pouches without complete safety data on the pouch material. Leppanen, who led a microplastics exposure project a…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Former Akero executives team up with Fairmount to launch new immunology company
    The former executive team of Akero Therapeutics, which was recently acquired by Novo Nordisk, has announced the formation of a new immunology-focused company. They are partnering with investment fi…
    STAT · 1mo agoNeutral↗ source
  • STAT outlines 12 actionable steps to curb U.S. alcohol-related deaths
    STAT's investigative series examined the U.S. alcohol epidemic by interviewing over a hundred researchers, clinicians, patients, industry insiders and lawmakers. The reporters also reviewed scienti…
    STAT · 1mo agoPositive↗ source
  • Nominee for HHS emergency response role has a history of questioning vaccines
    Sean Kaufman has been selected by the administration to lead the Office of Assistant Secretary for Preparedness and Response, overseeing the nation’s reaction to public health emergencies and disas…
    STAT · 1mo agoRegulatoryNegative↗ source
  • FDA delays deadline for electric shock device ban
    The Food and Drug Administration has quietly moved the enforcement date for the ban on certain electric shock devices to a later point in time. The agency did not issue a high‑profile announcement,…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Transplants extended survival for patients whose stage 4 lung cancer hadn’t spread, study says
    Lung cancer patients hadn't been seen as candidates for organ transplant. Now a study finds patients did well.
    STAT · 1mo ago↗ source
  • STAT+: Prime Medicine claims victory in dispute over gene-editing technology with Beam Therapeutics
    Prime Medicine said it had won an arbitration dispute against Beam Therapeutics, a clash that had pitted two well-backed gene-editing companies against each other.
    STAT · 1mo ago↗ source
  • HHS responds coolly to paper on alcohol risk
    Soda and liver cancer, scientists conflicted on a new NIH proposal, and more health news from Morning Rounds
    STAT · 2mo ago↗ source
  • Gilead and Merck’s latest trial success and flop
    AstraZeneca's GLP-1 pill, GSK's $10.6B cancer startup acquisition, and more biotech news from The Readout
    STAT · 2mo ago↗ source
  • Alcohol study discarded by Trump officials is published in scientific journal
    A government-commissioned study had been meant to inform new dietary guidelines, and found risks associated with even light drinking.
    STAT · 2mo ago↗ source
  • STAT+: AstraZeneca’s GLP-1 pill shows promise in obesity, diabetes trials
    AstraZeneca’s GLP-1 pill showed promise in mid-stage obesity and diabetes studies, but it may still be too early to determine how it stacks up against other oral treatments.
    STAT · 2mo ago↗ source
  • STAT+: New data may cast doubt on competitiveness of Boehringer’s obesity drug
    Boehringer Ingelheim’s obesity drug showed promise in cutting liver fat, but it was less impressive at overall weight loss, new data shows.
    STAT · 2mo ago↗ source
  • Opinion: Grail’s multi-cancer early detection trial was negative. But as an oncologist, I see more to this story
    An oncologist shares three lessons from the world’s first randomized trial on a multi-cancer early detection.
    STAT · 2mo ago↗ source