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  • GSK licenses Chimagen trispecific T-cell engager for up to $750 million, targeting phase-1 multiple myeloma study
    GSK has entered a licensing agreement with China’s Chimagen Biosciences that could be worth as much as $750 million. The deal will allow GSK to begin phase‑1 testing of a trispecific T‑cell engager…
    Fierce Biotech · 7h agoDealPositive↗ source
  • FDA approves Telix's Pixclara, first FET-PET imaging drug for glioma in the U.S.
    The U.S. Food and Drug Administration has granted approval to Telix Pharmaceuticals' Pixclara, a fluorine‑18 labeled amino acid PET tracer designed for imaging gliomas. This marks the first FDA‑cle…
    Fierce Biotech · 9h agoRegulatoryPositive↗ source
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Psychiatry & CNS909
Ophthalmology524
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Infectious Disease464
  • Johnson & Johnson’s depression drug JNJ-5120 fails primary endpoint in phase 2 trial
    A phase 2 study of JNJ-5120, an M1 receptor antagonist developed by Johnson & Johnson with Contineum Therapeutics, did not meet its primary efficacy endpoint in patients with major depressive disor…
    Fierce Biotech · 9h agoNegative readoutNegative↗ source
  • Novo abandons $285 million partnership with Ascendis for monthly GLP-1 obesity drug
    Novo Nordisk, which recently rebranded, has terminated a licensing agreement with Ascendis Pharma that was originally valued at up to $285 million. The collaboration, signed in November 2024, was…
    Fierce Biotech · 8h agoDealNegative↗ 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 · 17h 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 · 21h 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 · 1d agoApprovalPositive↗ source
  • FDA holds hearing on access and safety as psychedelic drug approval looms
    The Food and Drug Administration convened a public hearing to collect input on how emerging psychedelic medicines should be used, monitored, and continuously studied as a potential first approval a…
    Fierce Biotech · 20h agoRegulatoryNeutral↗ source
  • Corbus reports phase 1b obesity data showing lower neuropsychiatric side effects for CB1 antagonist
    Corbus Pharmaceuticals released results from a phase 1b trial of its CB1 inverse agonist aimed at treating obesity. The study indicated the drug lowered rates of depression, anxiety, irritability a…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Cellectis drops its allogeneic CAR-T candidates lasme-cel and eti-cel amid rising competition from in-vivo therapies
    Cellectis announced it is terminating development of its two allogeneic CAR-T programs, lasme-cel for B-cell acute lymphoblastic leukemia and eti-cel for non-Hodgkin lymphoma. The move reflects a…
    Fierce Biotech · 1d agoNegative↗ 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 · 22h agoNegative↗ source
  • Eli Lilly halts early-stage obesity drug LY4064912 after failing to meet development criteria
    Eli Lilly announced it is ending development of its early-stage obesity candidate, LY4064912, after the phase 1 study did not achieve the company’s expectations. The first‑in‑human trial enrolled…
    Fierce Biotech · 1d agoNegative↗ source
  • Electra Therapeutics targets up to $342M IPO to fund phase 2/3 study of ipsoprubart for rare inflammatory syndrome
    Electra Therapeutics, based in South San Francisco, filed with the SEC indicating plans to sell 21.7 million shares at $14‑$16 each. The company expects net proceeds of about $296.6 million, poten…
    Fierce Biotech · 1d agoDealNeutral↗ 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 · 1d agoPositive readoutNeutral↗ source
  • Axoltis Phase 2 ALS Trial Fails Primary Endpoint Though Shows Some Secondary Trends
    Axoltis Pharma reported that its phase 2 study of the synthetic peptide NX210c in amyotrophic lateral sclerosis did not meet its primary goal. The double‑blind, randomized trial enrolled 82 French…
    Fierce Biotech · 1d agoNegative readoutNegative↗ source
  • Novo rebrands, drops 'Nordisk' to become simply 'Novo' in market push
    Novo Nordisk announced a major rebranding that will see the company drop the "Nordisk" part of its everyday brand. The legal name Novo Nordisk A/S remains unchanged, but the company will be known s…
    Fierce Biotech · 1d agoPositive↗ source
  • J&J nears $20 billion sale of DePuy Synthes orthopedics unit to Apollo
    Johnson & Johnson is in advanced talks to sell its DePuy Synthes orthopedics business to private-equity firm Apollo Global Management for roughly $20 billion, according to Bloomberg. The deal woul…
    Fierce Biotech · 2d agoDealNeutral↗ 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 · 2d 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 · 3d agoPositive readoutPositive↗ 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 · 4d 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 · 4d agoPositive readoutPositive↗ source
  • Definium Therapeutics clinches third phase-3 win for LSD anxiety drug, eyes FDA filing
    Definium Therapeutics reported another successful phase 3 trial of its LSD‑based anxiety treatment, DT120 ODT. The Panorama study enrolled 245 patients and compared a 100 µg dose of DT120 with pla…
    Fierce Biotech · 3d agoPositive readoutPositive↗ 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 · 4d agoApprovalPositive↗ 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