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  • FDA makes permanent four key leadership appointments, including first AI deputy commissioner
    The Food and Drug Administration announced that three officials who have been serving in acting capacities will now be confirmed as permanent heads of its major centers. Michael Davis, a psychiatr…
    STAT · 2d agoRegulatoryPositive↗ source
  • FDA halts US shipments from Shoolin Pharma after unsanitary inspection findings
    The Food and Drug Administration issued a warning letter to Shoolin Pharma after an April inspection uncovered unsanitary conditions at its Gujarat facility. The letter cited residue and stains on…
    STAT · 2d agoRegulatoryNegative↗ source
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  • Moonwalk Biosciences raises $70M and pivots to RNAi obesity drug development
    Moonwalk Biosciences, a California biotech founded in 2024, announced a new $70 million venture funding round. The capital will support development of its first obesity drug, which uses RNA interf…
    BioPharma Dive · 2d agoDealPositive↗ source
  • Roivant's mosliciguat shows strong Phase 2 results, advancing to Phase 3 for PH-ILD
    Mosliciguat, the pulmonary hypertension candidate from Roivant Sciences subsidiary Pulmovant, cut pulmonary vascular resistance by more than 56% in a Phase 2 trial of patients with PH‑ILD, surpassi…
    BioSpace · 2d agoPositive readoutPositive↗ source
  • Moonwalk Biosciences raises $70M to move RNAi obesity drug MW101 toward first-in-human trials in 2027
    Moonwalk Biosciences, an obesity drug developer backed by Eli Lilly, announced a $70 million Series B financing. The funding will support its lead RNAi candidate, MW101, which in mouse studies pro…
    BioSpace · 2d agoDealPositive↗ source
  • Novartis' pelacarsen fails Phase 3, casting doubt on Lp(a) lowering strategy
    Novartis announced that its antisense drug pelacarsen failed to meet the primary endpoint in the Phase 3 Lp(a)HORIZON trial. The study was intended to determine whether the drug’s ability to lower…
    BioSpace · 2d agoNegative readoutNegative↗ source
  • Inhibrx reports promising responses to OX40 immunotherapy in HPV-positive head and neck cancer
    Inhibrx announced that its experimental immunotherapy targeting the protein OX40 produced measurable responses in patients with head and neck cancer, with the clearest activity observed in a small…
    STAT · 2d agoPositive readoutPositive↗ source
  • Benelux’s strong science base eyed for biotech scaling despite funding gaps
    Belgium and the Netherlands have built some of Europe’s strongest life‑science ecosystems, anchored by leading research institutions and a growing pool of biotech talent. Early‑stage capital remai…
    BioSpace · 2d agoPositive↗ source
  • AI can transform drug discovery only when its strengths are properly leveraged
    The article notes a split narrative in the industry, with some headlines promising AI will speed drugs to market while others warn it could waste resources. Thomas M. Kaiser, a medicinal chemist,…
    BioSpace · 2d agoNeutral↗ source
  • FDA approves AstraZeneca breast cancer drug despite negative advisory committee vote; Novartis faces cholesterol drug setbacks
    The U.S. Food and Drug Administration granted approval to AstraZeneca's breast cancer therapy even though the advisory committee voted against it. The decision underscores the agency's willingness…
    raps · 2d agoRegulatoryNeutral↗ source
  • Six AI agents run on a deskside system to deliver on-premises clinical decision support
    Healthcare organizations have long struggled to balance the promise of artificial intelligence with the need to keep patient data secure. Cloud‑based large language models can provide powerful clin…
    BioPharma Dive · 1d agoPositive↗ source
  • UnitedHealth executives donate heavily to Rep. Katherine Clark as No Surprises Act debate intensifies
    UnitedHealth Group's senior leadership, including CEO Stephen Hemsley, recently made sizable campaign contributions to Rep. Katherine Clark of Massachusetts. Clark, the House Democratic leader who…
    STAT · 2d agoRegulatoryNeutral↗ source
  • Democrats outline health-care priorities as they aim to retake House before November midterms
    The article notes that Democrats are sharpening their health‑care proposals as the November midterm elections approach, signaling a more detailed agenda should they regain control of the House. Ho…
    STAT · 2d agoRegulatoryNeutral↗ source
  • Administrative gap stalls access to new pancreatic cancer therapy
    A recent Morning Rounds report notes that patients awaiting a new pancreatic cancer treatment are encountering delays because an administrative gap has halted its rollout. The story explains that…
    STAT · 2d agoRegulatoryNegative↗ source
  • Reynolds launches fruit-flavored Vuse Pro vapes in Ohio despite lacking FDA authorization
    Reynolds American has begun selling its Vuse Pro e‑cigarettes in four new flavors-peach, berry, watermelon and fresh mint-at a GetGo station in suburban Ohio and in a few other states. The product…
    STAT · 2d agoRegulatoryNegative↗ source
  • EMA publishes guidance on voluntary electronic product information submissions for EU MAAs
    The European Medicines Agency released new guidance detailing how companies should provide electronic product information (ePI) when filing marketing authorization applications under the EU's centr…
    raps · 2d agoRegulatoryNeutral↗ source
  • Oura files for IPO after reporting $1.2 billion in earnings
    Oura, the maker of popular health tracking rings, announced it will go public through an initial public offering. The company disclosed that it generated $1.2 billion in earnings during its most r…
    STAT · 2d agoDealPositive↗ source
  • UnitedHealth executives donate over $100,000 to Rep. Katherine Clark ahead of midterms
    UnitedHealth Group’s chief executive Stephen Hemsley and other senior leaders gave campaign contributions to Rep. Katherine Clark, a top Democrat in the House. The contributions total more than $1…
    STAT · 2d agoNeutral↗ source
  • Four CDMOs to watch as biopharma outsourcing grows
    The article lists four contract development and manufacturing organizations (CDMOs) that biopharma companies can partner with as demand for external development and manufacturing rises. Lonza, bas…
    BioSpace · 2d agoNeutral↗ source
  • Experts say gloves are unnecessary for flu shots, urging a shift to reduce waste
    Cassandra Thiel, an assistant professor of population health, and Preeti Jaggi, a pediatrics professor, note that they regularly see vaccination technicians sanitize their hands, put on nitrile glo…
    STAT · 2d agoPositive↗ source
  • Medical student speaks out against weight bias in clinical training
    A fourth‑year medical student at Tufts University School of Medicine describes being called out for wearing plus‑size scrubs and feeling singled out in the operating room. She recounts a nurse’s c…
    STAT · 2d agoPositive↗ source
  • Novo Nordisk halts two cardiovascular trials of inflammation-targeting drug ziltivekimab
    Novo Nordisk announced it is halting the HERMES and ATHENA cardiovascular trials of its experimental drug ziltivekimab, which was intended to lower inflammation to improve heart health. A data mon…
    STAT · 3d agoNegative readoutNegative↗ source
  • ADA panel still reviewing expulsions from June conference, further actions possible
    The American Diabetes Association released top‑line findings on Sept. 1 from an internal panel tasked with reviewing the June 5 expulsion of five members at its New Orleans conference. The full re…
    STAT · 3d agoNegative↗ source
  • Novartis and Ionis's pelacarsen fails to cut heart events despite lowering Lp(a) levels
    Novartis and Ionis reported that pelacarsen, an RNA therapy aimed at lowering lipoprotein(a), did not reduce major cardiovascular events in a Phase 3 trial of over 8,000 patients. The study compare…
    BioPharma Dive · 5d agoNegative readoutNegative↗ source
  • STAT readers weigh in on MD vs DO training, AI accountability and surrogacy in medicine
    STAT’s First Opinion platform invites letters that respond to its essays, and a recent submission addresses several hot topics in health care. The writer acknowledges the bias that osteopathic gra…
    STAT · 5d agoNeutral↗ source