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  • FDA approves Scholar Rock's muscle-targeted SMA therapy Isembyld
    The Food and Drug Administration has approved a new medication for spinal muscular atrophy (SMA). The drug, apitegromab marketed as Isembyld, is the first muscle-targeted therapy for the disease.…
    BioPharma Dive · 4h agoApprovalPositive↗ source
  • AstraZeneca’s Etcamah fails Phase 3 trial, dashing hopes for $2.9 billion breast cancer market
    AstraZeneca’s oral selective estrogen receptor degrader Etcamah was evaluated in the Phase 3 SERENA-4 trial as a first-line option for patients with ER-positive, HER2-negative advanced breast cance…
    BioSpace · 4h agoNegative readoutNegative↗ source
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Psychiatry & CNS901
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Endocrinology & Metabolism497
Infectious Disease464
  • 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 · 13h agoApprovalPositive↗ source
  • Scholar Rock receives FDA approval for Isembyld, first muscle-targeted SMA therapy
    Scholar Rock announced that its monoclonal antibody apitegromab, branded Isembyld, has been cleared by the FDA for treatment of spinal muscular atrophy (SMA). The approval follows a previous rejec…
    BioSpace · 5h agoApprovalPositive↗ source
  • BioNTech's anti-CTLA-4 drug shows survival advantage in advanced squamous lung cancer at WCLC
    BioNTech, together with partner OncoC4, presented new overall survival data at the World Conference on Lung Cancer in South Korea, joining other companies such as Summit Therapeutics, GSK and Roche…
    BioSpace · 2h agoPositive readoutPositive↗ source
  • Cellectis abandons CAR-T programs, shifts focus to in vivo gene editing
    Cellectis announced it will discontinue its donor-derived CAR‑T programs and redirect its efforts toward in vivo gene‑editing medicines. The company said the commercial and clinical landscape for…
    BioPharma Dive · 1h agoNegative↗ source
  • Definium's LSD candidate DT120 shows positive Phase 3 results, moving toward FDA submission
    Definium Therapeutics reported positive topline data from its Phase 3 Panorama trial of DT120, an oral LSD formulation for generalized anxiety disorder (GAD). The trial met its primary endpoint, s…
    BioSpace · 3h agoPositive readoutPositive↗ source
  • Novo drops Nordisk from name, rebrands as Novo with new bull logo
    Novo Nordisk announced it will drop the "Nordisk" part of its name, rebranding simply as Novo and rotating the iconic Apis bull in its logo to signal a new direction. CEO Mike Maziar Doustdar said…
    BioSpace · 4h agoNeutral↗ source
  • 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 · 13h 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 · 13h 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 · 10h 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 · 12h agoPositive↗ source
  • AstraZeneca’s newly approved pill fails frontline breast cancer study
    Etcamah is the second oral “SERD” to recently fall short in first-line breast cancer, following a similar setback from Roche earlier this year.
    BioPharma Dive · 1h ago↗ 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 · 3d 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
  • 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
  • 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 · 3d 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 · 3d 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 · 3d agoDealNeutral↗ source
  • Centric Compounding recalls Glutathione, Myer’s Cocktail and Tri-Immune Boost injectables over elevated endotoxin levels
    Centric Compounding LLC announced a voluntary recall of six lots of its injectable products Glutathione 200 mg/mL, Myer’s Cocktail and Tri-Immune Boost. The recall was issued on September 9, 2026 a…
    fda recalls · 3d agoRegulatoryNegative↗ 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 · 3d agoDealNeutral↗ 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 · 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 · 3d agoNeutral↗ source