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1,242 stories matching this filter · ← front page

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  • Biopharma workers increasingly postpone retirement, poll shows 52% plan to stay longer
    Biopharma professionals are rethinking retirement, with a BioSpace LinkedIn poll indicating that 52% expect to retire later than originally planned. Overall, 63% of respondents said they have chang…
    BioSpace · 1mo agoNeutral↗ source
  • Novartis to pay $125M for blood-brain barrier crossing platform
    Proceeds from the deal, which hands Novartis global rights to a technology developed by Sironax, will help advance three candidates that the startup says have “best-in-class” potential.
    BioPharma Dive · 1mo ago↗ source
  • Sling banks $123M for an experimental thyroid eye disease pill
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A confirmatory late-stage study is now also underway for what the startup is positioning as, potentially, the first oral alternative to approved injectables like Amgen's Tepezza and Viridian's Lumvoa.
BioPharma Dive · 1mo ago↗ source
  • FDA approves first generic radioligand therapy for neuroendocrine tumors as Sionna announces major layoffs
    The U.S. Food and Drug Administration has cleared Bexlutry, the first generic version of Novartis’ Lutathera, marking the debut of a radioligand therapy that can be used for SSTR‑positive neuroendo…
    BioPharma Dive · 1mo agoApprovalNeutral↗ source
  • New antibody-drug conjugates show promise as potential standard for extensive-stage small cell lung cancer at WCLC 2026
    The World Conference on Lung Cancer showcased several late‑stage trial updates, with a focus on new therapies for small cell lung cancer, the more aggressive form of the disease. Antibody‑drug con…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • GSK to acquire Chimagen’s trispecific T-cell engager program in deal up to $750 million
    GSK announced it will acquire a preclinical trispecific T cell engager program from Chinese biotech Chimagen Biosciences in a transaction that could total up to $750 million. The agreement provide…
    BioSpace · 1mo agoDealPositive↗ source
  • FDA launches Operation TrialBlazer to accelerate early-stage drug trials and bring research back to the U.S.
    The FDA announced it is now accepting applications for Operation TrialBlazer, an expedited IND pilot program. The program pairs drug sponsors with qualified U.S. research institutions to cut the r…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • FDA launches pilot to accelerate early-stage drug trials in the United States
    The FDA announced a new pilot program called the Expedited Investigational New Drug Pilot as part of Operation Trialblazer. The initiative will pair up to ten qualified research institutions with…
    BioPharma Dive · 1mo agoRegulatoryPositive↗ source
  • Stakeholders call on FDA to set safety and treatment standards for emerging psychedelic therapies
    At a recent public hearing, experts and other stakeholders emphasized the need for clear safety and access guidelines as psychedelic medicines move closer to market. The FDA is intensifying effort…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • FDA Opens Expedited IND Pilot to Speed First-in-Human Trials, Applications Accepted Through Oct. 30
    The U.S. Food and Drug Administration announced the final design of an Expedited IND Pilot aimed at shortening the time from drug discovery to first-in-human trials. The pilot pairs drug developer…
    fda press · 1mo agoRegulatoryNeutral↗ source
  • Cullinan-Taiho eye FDA filing for zipalertinib after trial shows strong PFS benefit despite three deaths
    Cullinan Therapeutics and its partner Taiho Oncology said they will seek FDA approval for zipalertinib, an oral therapy for a subset of non‑small cell lung cancer, based on data from a late‑stage s…
    BioSpace · 1mo agoPositive readoutNeutral↗ source
  • Blood centers poised to boost cell and gene therapy supply chains
    Blood centers have the donors, resources and community footprint that drug sponsors need to address supply chain bottlenecks for cell and gene therapies. Cell and gene therapies such as CAR‑T and…
    BioSpace · 1mo agoPositive↗ source
  • GSK to cut 650 jobs as it shuts German vaccine plant and consolidates production in Canada
    GSK announced it will close its vaccine manufacturing facility in Dresden, Germany, resulting in about 650 layoffs. The decision follows a review and aligns with a $2.5 billion cost‑saving program…
    BioSpace · 1mo agoLayoffsNegative↗ source
  • Rare disease reform, CMC risk, reshoring US trials top of mind ahead of PDUFA VIII meeting
    The FDA gathers Wednesday to hear what industry stakeholders and the public want included in the latest iteration of the Prescription Drug User Fee Act that sets the agency’s priorities for fiscal…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • Summit and Akeso report ivonescimab extends lung cancer survival by eight months versus Keytruda in Phase 3 trial
    Summit Therapeutics and its partner Akeso said their experimental dual-target drug ivonescimab added about eight months of overall survival for patients with lung cancer compared with Merck's Keytr…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ 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 · 1mo agoApprovalPositive↗ source
  • 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 · 1mo 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 · 1mo agoNegative readoutNegative↗ source
  • 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 · 1mo agoApprovalPositive↗ source
  • AAM warns that price pressures threaten sustainability of US generics and biosimilars market
    The Association for Accessible Medicines (AAM) issued its annual report warning that the economics of off‑patent drugs have deteriorated, putting the sustainability of the generic and biosimilar ma…
    BioSpace · 1mo agoRegulatoryNegative↗ 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoNeutral↗ source