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3,041 stories matching this filter · ← front page

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  • FDA approves AstraZeneca's oral SERD Etcamah for HR+/HER2-negative advanced breast cancer
    FDA granted approval to AstraZeneca's camizestrant, marketed as Etcamah, an oral selective estrogen receptor degrader (SERD) for a specific subset of advanced breast cancer patients. The indicatio…
    BioSpace · 2mo agoApprovalPositive↗ source
  • BrainChild Bio secures $119M Series A to advance CAR-T therapy for deadly pediatric brain tumor
    BrainChild Bio announced a $119 million Series A financing round aimed at moving its CAR‑T programs for central nervous system cancers in children forward. The company’s lead candidate, BCB-276, w…
    BioSpace · 2mo agoDealPositive↗ source
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  • Rural hospitals seek partnership deals as Trump Medicaid cuts threaten financial stability
    Rural health systems are looking for mergers or partnership agreements to stay afloat as the Trump administration prepares unprecedented cuts to Medicaid funding. The anticipated reductions are pr…
    STAT · 2mo agoDealNegative↗ source
  • Moderna and Merck’s personalized mRNA cancer vaccine success spurs industry shift to faster, smaller-scale production
    After mastering large‑scale mRNA manufacturing during the COVID‑19 pandemic, the sector is now turning its attention to delivering individualized vaccines to patients quickly. The recent clinical…
    BioSpace · 2mo agoPositive↗ source
  • Parkinson's drug pipeline diversifies as firms seek disease-modifying therapies
    Several pharmaceutical companies are shifting away from the traditional alpha-synuclein antibody strategy and exploring alternative mechanisms to treat Parkinson's disease. AC Immune is highlighted…
    BioSpace · 2mo agoNeutral↗ source
  • 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 · 2mo 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 · 2mo agoRegulatoryNegative↗ 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo agoRegulatoryNeutral↗ 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo agoPositive↗ source
  • FreshPoint recalls 1,093 Cranberry Chicken Salad Sandwiches over undeclared egg allergen
    FreshPoint Central Florida announced a voluntary recall of its Cranberry Chicken Salad Wedge sandwiches after discovering an egg allergen was not listed in the "Contains" statement on the packaging…
    fda recalls · 2mo agoCRLNegative↗ 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 · 2mo agoPositive↗ source