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2,147 stories matching this filter · ← front page

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  • FDA grants accelerated approval to AstraZeneca’s Etcamah, enabling ctDNA-guided therapy for HR-positive breast cancer
    The FDA issued an accelerated approval for AstraZeneca’s oral selective estrogen receptor degrader camizestrant, to be sold as Etcamah, marking a rare departure from its advisory committee’s recomm…
    Fierce Biotech · 9h agoApprovalPositive↗ source
  • 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 · 11h agoApprovalNeutral↗ source
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Infectious Disease444
  • 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 · 8h agoPositive readoutPositive↗ source
  • AstraZeneca’s IL-33 antibody tozorakimab earns FDA priority review after COPD trial cuts exacerbations by up to 34%
    AstraZeneca’s R&D chief medical officer Sharon Barr said the company’s latest data on its IL-33 inhibitor represents an internal “science success story.” The results have earned the drug a priority…
    Fierce Biotech · 9h agoPositive readoutPositive↗ source
  • Boston Scientific recalls spinal cord stimulator leads after over 1,000 serious injuries
    Boston Scientific announced a recall of its Infinion CX spinal cord stimulation leads after the FDA classified the action as the most serious level. The recall, issued June 17, covers all unused l…
    Fierce Biotech · 11h agoCRLNegative↗ source
  • 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 · 5h 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 · 9h 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 · 12h agoNegative readoutNegative↗ source
  • Novartis' experimental drug fails pivotal trial for rare neuromuscular disease
    Novartis reported that its experimental therapy for a rare neuromuscular disorder did not improve muscle function in a pivotal study, missing its primary endpoints. The failure represents the comp…
    STAT · 6h agoNegative readoutNegative↗ source
  • Novartis' del-desiran misses primary goal in late-stage myotonic dystrophy trial
    Novartis announced that its experimental RNA drug del-desiran did not achieve the primary endpoint in a late-stage study of myotonic dystrophy type 1, a rare muscle‑weakening disease. The trial me…
    BioPharma Dive · 6h 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 · 8h agoDealPositive↗ source
  • Spyre Therapeutics reports positive Phase 2 results for anti-IL-23 antibody SPY003 in ulcerative colitis
    Spyre Therapeutics announced that its anti‑IL‑23 antibody, SPY003, achieved its primary and secondary goals in a Phase 2 ulcerative colitis study. The trial, part A of the Skyline program, enrolled…
    Fierce Biotech · 10h agoPositive readoutPositive↗ source
  • BMS CAR-T therapy arlo-cel meets primary endpoint in pivotal multiple myeloma trial
    Bristol Myers Squibb reported that its GPRC5D-directed CAR-T cell therapy, arlo-cel, achieved the primary endpoint in the pivotal Quintessential trial for multiple myeloma. The study enrolled pati…
    Fierce Biotech · 10h agoPositive readoutPositive↗ 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 · 11h agoDealNegative↗ 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 · 2h agoRegulatoryNegative↗ source
  • 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 · 3h agoDealPositive↗ 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 · 8h agoPositive readoutPositive↗ source
  • Pharvaris reports 83% drop in hereditary angioedema attacks in phase 3 trial, FDA decision pending
    Pharvaris announced that its oral bradykinin B2 receptor antagonist, deucrictibant, met the primary goal in a second phase 3 study. The trial, called CHAPTER-3, enrolled 85 patients with three for…
    Fierce Biotech · 10h 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 · 16h agoNegative readoutNegative↗ source
  • Inhibrx reports 9.6-month median PFS for OX40 agonist combo in phase 2 head-neck cancer trial
    Inhibrx Biosciences presented updated data from its phase‑2 HexAgon study of the hexavalent OX40 agonist INBRX‑106 combined with Merck’s Keytruda in patients with untreated metastatic or unresectab…
    Fierce Biotech · 19h agoPositive readoutPositive↗ 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 · 4h 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 · 5h 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 · 8h 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 · 11h 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 · 5h agoDealPositive↗ source