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1,354 stories matching this filter · ← front page

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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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  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Novartis shares tumble 13% after three late-stage drug setbacks hit market
    Novartis' stock dropped more than 13% this week after three of its late-stage programs reported setbacks, pulling down other pharma stocks. The antibody-oligonucleotide conjugate del-desiran faile…
    BioSpace · 3d agoNegative readoutNegative↗ source
  • Revolution Medicines secures FDA approval for Rasonque, a RAS inhibitor targeting advanced pancreatic cancer
    Revolution Medicines announced FDA approval of its RAS inhibitor Rasonque for patients with advanced pancreatic cancer, marking a milestone for the company. The approval is seen as a breakthrough…
    Fierce Biotech · 3d agoApprovalPositive↗ source
  • Novartis board under fire as two late-stage trials fail and CAR-T program paused
    Novartis' board is facing heightened investor scrutiny after the Swiss drugmaker reported failures in two pivotal late-phase trials, raising doubts about its capital deployment strategy for growth…
    BioSpace · 3d agoNegative readoutNegative↗ source
  • Samsung Biologics secures $262 million manufacturing contract with European pharma firm
    Samsung Biologics announced a $262 million agreement to provide manufacturing services to an unnamed European pharmaceutical company. The contract runs through 2033. The deal will be executed at S…
    BioSpace · 2d agoDealPositive↗ source
  • Frazier Life Sciences raises over $1.1 billion for its small-mid-cap biotech fund, total commitments now $2.8 billion
    Frazier Life Sciences announced that it has added more than $1.1 billion in new capital to its public fund that targets small and mid‑size biopharma companies. The infusion brings the fund's total…
    BioSpace · 2d agoDealPositive↗ source
  • RA Capital backs four biotech rounds in September as Novartis shares tumble after trial setbacks
    RA Capital Management participated in four biotech financings in September, including Series A rounds for Solstice Oncology and Tectora Therapeutics, as well as co-leading a $56 million round for T…
    BioPharma Dive · 2d agoDealNeutral↗ source
  • Karyopharm Secures One-Month Debt Extension While Awaiting Xpovio Decision
    Karyopharm Therapeutics, facing cash constraints, has negotiated a temporary reprieve on a $15.8 million debt that was due. Under the agreement, lenders and noteholders will refrain from enforceme…
    BioPharma Dive · 2d agoDealNeutral↗ source
  • FDA pushes back decision on Exelixis' zanzalintinib and Roche's Tecentriq combo for metastatic colorectal cancer
    The FDA announced a delay in its decision on the approval of Exelixis' oral kinase inhibitor zanzalintinib when used with Roche's Tecentriq for metastatic colorectal cancer. The agency said it nee…
    Fierce Biotech · 3d agoRegulatoryNegative↗ source
  • FDA leadership stabilizes under new CBER and CDER heads and appoints first AI deputy commissioner
    At the Food and Drug Administration, Karim Mikhail and Michael Davis have been confirmed as the permanent heads of the Center for Biologics Evaluation and Research and the Center for Drug Evaluatio…
    BioSpace · 3d agoRegulatoryPositive↗ source
  • mRNA cancer vaccines’ biggest barriers to market
    Manufacturing hurdles are just one challenge the industry must overcome to commercialize personalized mRNA cancer vaccines.
    BioPharma Dive · 2d agoRegulatoryNeutral↗ source
  • FDA plans study on barriers to women's enrollment in pregnancy exposure registries and announces PRV fee rates
    The Food and Drug Administration said it will conduct research into perceived barriers that limit women’s participation in pregnancy exposure registries. It also released the fee schedule for prio…
    raps · 3d agoRegulatoryNeutral↗ source
  • BioSpace to Host Webinar on Using Podcasts, Webinars and Thought Leadership for Pharma Marketing
    BioSpace announced a webinar that will walk PR, communications and marketing teams through the use of podcasts, webinars and thought‑leadership programs to raise executive visibility in biotech and…
    BioSpace · 2d agoNeutral↗ source