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  • FDA approves Moderna’s mRNA flu vaccine as company reports positive Phase 3 cancer vaccine results
    The FDA has granted approval to Moderna’s mRNA‑based flu vaccine, marking a notable rebound for the technology after the Trump administration cut $500 million in funding for mRNA programs a year ea…
    BioSpace · 7h agoApprovalPositive↗ source
  • Roche-MediLink’s B7-H3 ADC meets primary endpoint in phase 3 SCLC trial, median survival 13.3 months
    Roche and its partner MediLink reported phase 3 results for the B7-H3-directed antibody-drug conjugate (ADC) in small-cell lung cancer. The trial met its primary endpoint, with a median overall sur…
    Fierce Biotech · 6h agoPositive readoutNeutral↗ source
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Infectious Disease459
  • Public backing fuels FDA hearing on psychedelic therapies and potential COMP360 approval
    The FDA is holding a hearing on Monday to discuss the future of psychedelic drug development, after a wave of public comments expressed strong support for further research. Analysts say the suppor…
    BioSpace · 7h agoRegulatoryPositive↗ source
  • Merck and Moderna’s melanoma vaccine success spurs five rivals to chase personalized cancer vaccine breakthrough
    Merck and Moderna announced that their mRNA‑based cancer vaccine, given together with Merck’s Keytruda, extended progression‑free survival in patients with cutaneous melanoma in a late‑stage trial.…
    BioSpace · 7h agoPositive readoutPositive↗ source
  • Novo Nordisk rebrands as "Novo" to signal renewed focus amid slipping market share
    Novo Nordisk announced it will drop "Nordisk" from its name, adopting the shorter brand "Novo" along with a new slogan "Lasting Health Starts Now" as part of a cultural shift. The company says the…
    STAT · 2h agoNegative↗ source
  • Hospital leaders say GOP's $50 billion rural health fund falls far short of Medicaid cuts
    Republican lawmakers added a $50 billion Rural Health Transformation Fund to the tax‑cut legislation, aiming to help hospitals cope with planned Medicaid cuts. The fund represents only about 5 % o…
    STAT · 3h agoRegulatoryNegative↗ source
  • Cyclic peptide drugs gain traction as AI and hybrid synthesis aim to overcome manufacturing hurdles
    Oral cyclic peptides are attracting attention because they promise the convenience of small‑molecule drugs while delivering antibody‑like selectivity, a combination that is fueling interest after t…
    BioSpace · 4h agoNeutral↗ source
  • Opinion: Restoring public trust in science requires humility and collaboration, not just better messaging
    Michelle Groman and Caroline Montojo, presidents of The Greenwall Foundation and the Dana Foundation, wrote an opinion piece on Sept. 14, 2026 about the challenge of rebuilding public trust in scie…
    STAT · 3h agoNeutral↗ source
  • Sino Biological launches site-specific labeled proteins to aid cell surface research
    Cell surface proteins play key roles in immune signaling, cell adhesion and tissue maintenance, making them important targets for therapies and diagnostics. Researchers need reliable tools to dete…
    BioSpace · 6h agoPositive↗ source
  • Football fan wrestles with love for the game amid rising CTE concerns
    Michael Arkush, a sportswriter and New York Giants fan, reflects on his excitement for the 2026 season while confronting the growing awareness of chronic traumatic encephalopathy (CTE) in football.…
    STAT · 3h agoNeutral↗ source
  • Definium says its LSD drug notched another Phase 3 win in anxiety disorder
    Definium Therapeutics reported results Monday for its third Phase 3 readout this year on its oral LSD candidate, called DT120, and is gearing up for an FDA submission. The company’s late-stage data…
    Endpoints · 35m ago↗ source
  • STAT+: Definium’s LSD therapy eased anxiety in second large trial
    The first wave of biotechs is nearing regulatory approval for psychedelic therapies, a class of treatments that appear to exert rapid benefits.
    STAT · 35m ago↗ source
  • Cellectis cans allogeneic CAR-Ts to hop aboard in vivo bandwagon
    Cellectis may have kicked off the year promising “huge momentum” in the allogeneic CAR-T space, but even the French biotech has been unable to resist the dominance of in vivo options.
    Fierce Biotech · 6h ago↗ source
  • Analysis says secret Trump pharma deals could cut projected Medicare savings from MFN pricing by up to 80%
    A new analysis warns that confidential agreements between the Trump administration and more than two dozen drug makers could dramatically shrink the savings expected from the "most‑favored‑nation"…
    STAT · 13h agoRegulatoryNegative↗ source
  • Akeso and Summit report survival advantage for PD-1xVEGF combo over Keytruda
    At the American Society of Clinical Oncology (ASCO) 2026 meeting, Akeso Biopharma and its partner Summit Therapeutics announced new survival results for their experimental PD‑1×VEGF bispecific anti…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • GE HealthCare eyes $1 billion purchase of radiopharmaceutical developer Sofie Biosciences
    GE HealthCare is reported to be weighing a purchase of Sofie Biosciences, a radiopharmaceutical developer, for as much as $1 billion, according to the Financial Times. Sofie Biosciences, based in…
    Fierce Biotech · 1d agoDealNeutral↗ source
  • AstraZeneca's breast cancer pill camizestrant fails to improve progression-free survival in pivotal SERENA-4 trial
    AstraZeneca announced that its oral estrogen receptor degrader camizestrant, marketed as Etcamah, did not meet its primary endpoint in the phase III SERENA-4 trial. The study evaluated camizestran…
    STAT · 2d agoNegative readoutNegative↗ source
  • Novartis encounters setbacks while AI firm Anthropic searches for a dealmaker
    The latest Endpoints Weekly edition highlights a difficult period for Novartis, noting that the company is facing a series of setbacks. Details of the challenges are not provided, but the report s…
    Endpoints · 2d agoNeutral↗ source
  • FDA approves Isembyld, first therapy to target muscle loss in SMA patients
    Scholar Rock received FDA approval for Isembyld, the first drug designed to address muscle loss in spinal muscular atrophy (SMA). The approval covers adults and children aged two years and older w…
    STAT · 2d agoApprovalPositive↗ source
  • Cullinan and Taiho report six-month survival gain for EGFR exon 20 NSCLC in phase 3 trial
    Cullinan Therapeutics and Taiho Oncology presented interim data from their phase 3 Rezilient3 study, which evaluated the tyrosine kinase inhibitor zipalertinib combined with platinum‑based chemothe…
    Fierce Biotech · 2d agoPositive readoutPositive↗ source
  • Disc sets up polycythemia vera challenge but Silence maintains lead
    The polycythemia vera field is heating up, with Disc Medicine and Silence Therapeutics each advancing next-generation therapies, playing catch-up to Takeda and Protagonist Therapeutics, who won the…
    BioSpace · 2d agoApprovalPositive↗ source
  • Novartis shares tumble as three late-stage drug candidates fail trials
    Novartis' stock fell more than 13% this week after news that three of its late-stage programs did not meet expectations, pulling down other pharma stocks in the market. The antibody‑oligonucleotid…
    BioSpace · 3d agoNegative↗ source
  • BioNTech's gotistobart shows 18.5-month median survival in relapsed squamous lung cancer, beating docetaxel
    BioNTech presented updated data from its phase 3 Preserve-003 trial at the World Conference on Lung Cancer in Seoul. The trial compares its anti-CTLA-4 antibody gotistobart with standard chemothera…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source
  • Novartis and Novo Nordisk see back-to-back cardiovascular trial failures, raising doubts for the field
    Novartis announced that its experimental heart‑protective therapy, pelacarsen, did not meet its primary endpoints in a seven‑year study designed to cut heart attacks and strokes by lowering lipopro…
    STAT · 3d agoNegative readoutNegative↗ source
  • GSK’s risvutatug rezetecan shows 18.5-month median overall survival in phase 3 SCLC trial
    GSK, together with Chinese partner Hansoh Pharma, reported results of its antibody‑drug conjugate risvutatug rezetecan (ris‑rez) in a phase 3 trial for relapsed small‑cell lung cancer. The study e…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source