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GSK’s multiple myeloma trispecific gamble gets major funding step
GSK committed up to $750 million to secure global rights to Chimagen Biosciences’ Phase 1-ready tri-specific T-cell engager aimed at multiple myeloma. The deal positions GSK to pursue a...
FDA expedited IND pilot rolls out under ‘Operation Trialblazer’
The FDA opened an expedited investigational new drug (IND) pilot program to accelerate U.S. Phase 1 timelines and reduce regulatory hurdles, with the agency incorporating public feedback into...
Scholars Rock’s Isembyld wins FDA approval for SMA
The U.S. FDA approved Scholar Rock’s Isembyld (apitegromab-mstn), the myostatin inhibitor designed to increase muscle growth, for spinal muscular atrophy (SMA) in adults and children aged at least...
Telix wins FDA nod for first glioma FET-PET imaging agent
The FDA approved Telix Pharmaceuticals’ Pixclara (floretyrosine F-18; 18F-FET), making it the first FDA-approved FET-PET imaging agent for glioma and the first U.S.-approved PET...
GSK’s ROS1 NSCLC asset posts 94% ORR and pushes regulatory plans
GSK reported a 94% objective response rate for Jideytro (zidesamtinib) in a predefined cohort of TKI-naive patients with ROS1-positive advanced non-small-cell lung cancer (NSCLC) from its...
B7-H3 ADCs deliver overall survival gains in China trials of relapsed SCLC
Two B7-H3-directed antibody-drug conjugates—tambotatug pelitecan (tam-peli; YL-201) and risvutatug rezetecan (ris-rez)—met overall survival primary endpoints in China-based phase 3 trials in...
Vera lines up full approval push after strong 2-year IgAN Phase 3 results
Vera Therapeutics said final two-year Phase 3 data for Trutakna (deterioration pathway therapy for IgA nephropathy) strengthened its case for full FDA approval. The company reported that the drug...
Alzheimer’s biology gets a new resource: microprotein atlas of frontal cortex
Salk Institute researchers published what they describe as the first microprotein atlas of the human frontal cortex in Alzheimer’s disease, using transcriptomics, mass spectrometry, and...
Shingles pain mechanism: exosomes drive persistent neuronal dysfunction in PHN
Researchers at the University of Colorado Anschutz identified a mechanistic link between shingles and lingering post-herpetic neuralgia (PHN), reporting that circulating exosomes can sustain...
Radiopharmaceutical generics
The FDA cleared Curium’s “radioligand equivalent” to Novartis’ Lutathera, marking the first generic radioligand drug approval in the U.S. Curium’s decision establishes a new competitive lane for...
Big Pharma betting on next-gen T-cell engagers
GSK moved quickly to secure a trispecific T-cell engager from Chimagen Biosciences, committing up to $750 million to advance a multiple myeloma program. The asset is designed as a tri-specific...
FDA rare-disease trial framework review
The FDA launched a structured effort to pressure-test how it handles statistical trade-offs in rare-disease programs. Ahead of a Sept. 29 RISE workshop, the agency is seeking public input on the...
FDA expedited IND pilot to speed early trials
The FDA began accepting applications for an expedited investigational new drug (IND) pilot designed to make early-phase clinical development faster. The program, described as part of “Operation...
Rare neuromuscular approval: SMA gets muscle-targeting therapy
The FDA cleared Scholar Rock’s apitegromab (branded as Isembyld) for spinal muscular atrophy, positioning the drug as a first muscle-targeting therapy alongside existing SMA treatments. The...
Phase 3 durability signal for CTLA-4 lung cancer therapy
BioNTech said its CTLA-4 antibody gotistobart nearly doubled survival times in a lung cancer population studied in newly reported evidence. The company reported that previously treated patients...
Lung cancer ADCs and OS wins in China
Two B7-H3-directed ADCs, tambotatug pelitecan (tam-peli; YL-201) and risvutatug rezetecan (ris-rez), hit the overall survival endpoint in China-based Phase 3 trials in relapsed small-cell lung...
Major biotech exits: Cellectis shifts CAR-T strategy
Cellectis said it is quitting its CAR-T business and pivoting to “in vivo” gene editing. The French biotech cited a shifting therapeutic landscape and offloaded its lead programs as part of the...
GSK RNAi/antibody strategy plus clinical uncertainty elsewhere (Q2 reset)
Multiple updates in this batch point to a high-stakes portfolio recalibration across biotech. GSK’s $750 million bet on Chimagen’s tri-specific T-cell engager adds to the company’s immuno-oncology...
Clinical research mechanism: exosomes as driver of post-shingles nerve pain
Researchers at the University of Colorado Anschutz tied post-herpetic neuralgia (PHN) to circulating exosomes, reporting in Annals of Neurology that exosomes from PHN patients can trigger harmful...
FDA accelerates early-stage clinical development with new investigational pilot
The FDA has opened applications for its new expedited investigational new drug (IND) pilot program, as part of the agency’s “Operation Trialblazer.” Newly appointed permanent directors Karim...