Program aims to support CMC development of products with expedited clinical development timeframes and provide patients with earlier access to these products Detalimogene has already been manufactured ...
Investing.com -- enGene Holdings Inc (NASDAQ:ENGN) stock rose 2% on Tuesday after the FDA selected its bladder cancer therapy for a specialized manufacturing readiness program. The clinical-stage ...
If approved, DTX401 will be the first therapy approved to treat the underlying cause of GSDIaNOVATO, Calif., Dec. 30, 2025 ...
The company is enhancing its end-to-end platform to accelerate therapeutic development from early research to clinical trials.
Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that it has completed the rolling submission of its Biologics License Application (BLA) ...
CAMBRIDGE, Mass., Dec. 24, 2025 /PRNewswire/ -- Nona Biosciences, a global biotechnology company advancing biotherapeutic ...
The CNPV program significantly reduces drug review times, necessitating operational shifts for sponsors to meet compressed timelines. Sponsors must execute market access, pricing, and post-approval ...
Jessica Lin and Zhenqi (Pete) Shi from Genentech describe a novel machine learning approach to predicting retention times for ...
The Wegovy pill's approval signifies a shift from injectable to oral dosage forms, driven by patient preference for ...
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