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225 stories matching this filter · ← front page

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  • FDA advisory panel set to review Grail’s multi-cancer Galleri screening test
    An FDA advisory committee is scheduled to evaluate Grail’s Galleri blood test, which is designed to detect a range of cancers at an early stage. The panel will examine the test’s clinical data, pe…
    STAT · 8h agoRegulatoryNeutral↗ source
  • Sionna's CF add-on pill fails to improve outcomes in Phase 2 trial with Trikafta
    Sionna Therapeutics reported that its experimental cystic fibrosis pill, SION-719, did not provide any additional benefit when combined with Vertex Pharmaceuticals' Trikafta in a Phase 2 study. Th…
    STAT · 11h agoNegative readoutNegative↗ source
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fda recalls35
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643
Vaccines611
Endocrinology & Metabolism318
Ophthalmology313
Pain306
Infectious Disease300
  • FDA rejects ITM-11 radiopharmaceutical over manufacturing flaws, halting rival to Novartis therapy
    The U.S. Food and Drug Administration issued a rejection letter for ITM-11, a radiopharmaceutical therapy developed by ITM Isotope Technologies Munich, citing manufacturing problems that prevent ap…
    STAT · 8h agoRegulatoryNegative↗ source
  • Tenax Therapeutics’ heart-failure drug misses primary goal in Phase 3 trial, shares tumble
    Tenax Therapeutics announced that its experimental oral levosimendan failed to meet the primary efficacy endpoint in the Phase 3 LEVEL study, which evaluated treatment for a form of heart failure l…
    STAT · 11h agoNegative readoutNegative↗ source
  • Silence Therapeutics moves siRNA drug for polycythemia vera to Phase 3 after Phase 2 success
    Silence Therapeutics announced that its siRNA candidate divesiran achieved its primary endpoint in a Phase 2 study in patients with polycythemia vera, a rare blood cancer. The trial results showed…
    Endpoints · 11h agoPositive readoutPositive↗ source
  • Silence Therapeutics’ divesiran shows 88% response in Phase 2 polycythemia vera trial, challenging Takeda’s upcoming drug
    Silence Therapeutics reported results from a Phase 2 study of its RNA-based therapy divesiran in patients with polycythemia vera, a rare blood cancer that causes excessive red blood cell production…
    STAT · 11h agoPositive readoutPositive↗ source
  • AI’s role in medicine isn’t monolithic, says industry leader, urging nuanced adoption
    Priya Abani, CEO of health‑tech firm AliveCor, argues that asking whether AI is good for medicine is a question with an obvious answer: it is. She says the debate has become redundant and that the…
    STAT · 4d agoPositive↗ source
  • Only one third of US prostate cancer patients received pre-biopsy MRI in 2022, far below Western norms
    MRI is considered the standard pre-biopsy imaging tool for prostate cancer in most western nations, yet a new analysis shows that only about a third of US cases used it in 2022. In the United Stat…
    STAT · 5d agoNegative↗ source
  • Karyopharm stock tumbles after Phase 3 Xpovio trial fails in endometrial cancer
    Karyopharm announced that its Phase 3 XPORT-EC-042 study of Xpovio in endometrial cancer did not meet its primary endpoint. The failure represents the company's second unsuccessful attempt to expa…
    Endpoints · 10d agoNegative readoutNegative↗ source
  • Syphilis cases rise among unhoused drug users at San Diego-Tijuana border as researchers face NIH limits and penicillin shortage
    Researchers at the University of California San Diego have been working for years to build trust with unhoused people who use drugs on both sides of the San Diego‑Tijuana border. Their outreach has…
    STAT · 10d agoNegative↗ 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 · 11d agoNeutral↗ 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 · 11d agoRegulatoryNegative↗ 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 · 12d agoApprovalPositive↗ 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 · 13d agoNeutral↗ source
  • New name for PCOS aims to boost awareness and diagnosis for Black and Latina women
    Bontle Moka-Moliki, a 32-year-old from Atlanta, was diagnosed with endometriosis in 2019, fibroids a year later, and in 2024 received a diagnosis of a condition now called polyendocrine metabolic o…
    STAT · 13d agoPositive↗ source
  • FDA panel backs compounding pharmacies to make two peptides, rejects third
    The U.S. Food and Drug Administration’s advisory committee met on Friday and issued recommendations on the manufacturing of certain peptide drugs by compounding pharmacies. Committee members voted…
    STAT · 14d agoRegulatoryNeutral↗ source
  • Midwives urge role in combating medical misinformation as patients reject blood based on vaccine myths
    Midwife Mara Evans, based in North Carolina and faculty at Georgetown University’s Berkley School of Nursing, writes about her experience in a Nevada delivery room. She describes the careful handli…
    STAT · 14d agoNeutral↗ source
  • New AMA billing codes set to increase maternity care costs
    The American Medical Association, acting on a recommendation from the American College of Obstetrics and Gynecology, will end the use of global payment codes for deliveries at the end of this year.…
    STAT · 18d agoRegulatoryNegative↗ source
  • Congo Ebola outbreak kills 999, fastest recorded spread with no approved vaccine
    Official data from Congo’s Ministry of Health shows that 2,473 Ebola cases have been recorded and 999 deaths have occurred, with 737 patients still in isolation. The outbreak, declared on May 15,…
    STAT · 19d agoNegative↗ source
  • FDA approves Merck’s oral PCSK9 inhibitor Lipfendra, but cardiologists question its immediate impact
    The FDA has granted approval to enlicitide, marketed by Merck as Lipfendra, marking the first oral PCSK9 inhibitor for lowering blood cholesterol. The drug arrives as new clinical guidelines encou…
    STAT · 19d agoApprovalNeutral↗ source
  • Maui wildfire study proposes new rural health model for disaster recovery
    Researchers Alika Maunakea and Ruben Juarez are leading one of the largest investigations into the long‑term health effects of the 2023 Lahaina wildfires. The study follows more than 20 participant…
    STAT · 19d agoPositive↗ source
  • Study finds Merck’s Ervebo may protect against Bundibugyo Ebola strain, prompting calls for DRC testing
    New data from a human study published in the New England Journal of Medicine suggests Merck's Ervebo vaccine, licensed for the Zaire ebolavirus, may also offer protection against the Bundibugyo spe…
    STAT · 19d agoPositive readoutPositive↗ source
  • THC-infused drinks found on New York shelves near schools, often sold without ID and breaching state law
    A variety of cannabis-infused beverages are now stocked in grocery stores, bodegas and delis across New York City. Brands such as Oasis, Cann, Milonga, Cycling Frog, Tempters, Gigli and Mighty Kind…
    STAT · 20d agoRegulatoryNegative↗ source
  • Opinion: Beware the unintended consequences of testosterone screening for military servicemembers
    “I fear that the widespread rollout of testosterone screening may lead to some surprising and unintended consequences,” writes a urologist who studies testosterone.
    STAT · 23d 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 · 23d ago↗ source