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1,961 stories matching this filter · ← front page

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  • FDA approves Revolution Medicines’ pancreatic cancer drug Rasonque, but patients face delayed access
    The U.S. Food and Drug Administration has granted approval to Rasonque, a new therapy for pancreatic cancer developed by Revolution Medicines. The decision follows clinical data that showed the dru…
    STAT · 6h agoApprovalNeutral↗ source
  • AstraZeneca’s experimental COPD drug tozorakimab cuts flare-ups by 30% in Phase 3 trials
    In two Phase 3 studies, AstraZeneca’s injectable COPD candidate tozorakimab reduced the rate of disease exacerbations by roughly 30%, according to data released on Tuesday. The trials measured flar…
    STAT · 3h agoPositive readoutPositive↗ source
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fda recalls67
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fda press38
1145
Psychiatry & CNS866
Ophthalmology494
Pain478
Endocrinology & Metabolism468
Infectious Disease444
  • FDA approves AstraZeneca's new breast cancer therapy
    The U.S. Food and Drug Administration has granted approval for AstraZeneca's latest breast cancer drug, expanding treatment options for patients with the disease. The approval follows a review of…
    STAT · 44m agoApprovalPositive↗ source
  • Roivant's experimental pulmonary hypertension drug meets Phase 2 goals
    Roivant announced that its experimental drug mosliciguat achieved the primary endpoint in a 16‑week Phase 2 trial for pulmonary hypertension, a serious lung condition. The study showed a 56% reduc…
    STAT · 4h agoPositive readoutPositive↗ source
  • Novartis' DM1 drug del-desiran misses primary endpoint in Phase 3 HARBOR trial
    Novartis announced that its experimental therapy del-desiran did not improve muscle function in a pivotal Phase 3 study for myotonic dystrophy type 1 (DM1). The trial, called HARBOR, evaluated the…
    STAT · 7h agoNegative readoutNegative↗ source
  • BrainChild secures $116M to advance CAR-T therapies for rare pediatric brain tumors
    BrainChild Bio, a Seattle‑based biotech spun out of Seattle Children’s Hospital, announced it has raised $116 million in venture financing. The capital will fund the development of its CAR‑T cell t…
    BioPharma Dive · 3h agoDealPositive↗ source
  • 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 · 6h agoDealNegative↗ 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 · 3h agoPositive readoutPositive↗ source
  • Novartis' del-desiran fails primary endpoint in phase 3 Harbor trial for myotonic dystrophy type 1
    Novartis announced that its experimental therapy del-desiran did not meet the primary endpoint in the phase 3 Harbor trial, which evaluated improvement in video hand opening time in patients with m…
    Fierce Biotech · 11h agoNegative readoutNegative↗ 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 · 31m 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 · 3h 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 · 6h agoRegulatoryNegative↗ 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 · 35m 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 · 6h 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 · 6h 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 · 6h agoPositive↗ source
  • STAT+: Pharmalittle: We’re reading about another Novartis trial failure, a Novo Nordisk setback, and more
    An experimental Novartis drug for a rare neuromuscular condition failed to improve muscle function in a pivotal study
    STAT · 1h ago↗ source
  • Pharvaris' latest phase 3 win builds case for HAE drug with FDA verdict pending
    Pharvaris’ deucrictibant has tasted success in a second phase 3 study, strengthening the case for the therapy to treat hereditary angioedema patients as the Swiss biotech awaits an FDA approval dec…
    Fierce Biotech · 5h ago↗ source
  • Bristol Myers’ pivotal CAR-T multiple myeloma trial hits primary endpoint
    A pivotal trial of Bristol Myers Squibb’s GPRC5D-directed CAR-T cell therapy has hit its primary endpoint, furthering the drugmaker’s efforts to challenge Johnson & Johnson for the post-BCMA multip…
    Fierce Biotech · 5h ago↗ source
  • Boston Scientific recalls spinal cord implant in wake of more than 1k serious injuries
    Boston Scientific has issued another recall, this time for its spinal cord implant used to treat pain.
    Fierce Biotech · 6h ago↗ source
  • Inhibrx CEO says progression-free survival data leave ‘no question’ about OX40 agonist’s durability
    Inhibrx Biosciences’ CEO has argued that the 9.6 months of progression-free survival demonstrated by its OX40 agonist in a phase 2 study has proven the therapy’s durability in treating head and nec…
    Fierce Biotech · 14h ago↗ source
  • Novo Nordisk abandons two phase 3 trials of ziltivekimab, dimming blockbuster hopes
    Novo Nordisk announced it is terminating two late‑stage phase 3 studies of its IL‑6 ligand antibody ziltivekimab. The Hermes and Athena trials enrolled about 4,900 and 673 patients with heart fail…
    Fierce Biotech · 1d agoNegative readoutNegative↗ 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 · 1d agoNegative readoutNegative↗ source
  • BrainChild Bio masterminds $116M series A for CAR-T's pivotal push in pediatric brain cancer
    A startup spawned from Seattle Children’s Hospital has raised a $116 million series A to advance cell therapies for devastating childhood brain tumors.
    Fierce Biotech · 1d agoNeutral↗ source
  • ADARx, backed by AbbVie, files for IPO to fund clinical-stage siRNA programs
    ADARx Pharmaceuticals, a San Diego biotech supported by AbbVie, announced plans to pursue an initial public offering. The company says most of the IPO proceeds will be used to advance three clinic…
    Fierce Biotech · 2d agoDealPositive↗ source