The marketing submission targeted at patients with moderate-to-severe acute pain is on track to be completed in Q2 2024. Citing a recent end-of-phase 2 meeting with the FDA, the cystic fibrosis ...
Shares of Ultragenyx Pharmaceutical RARE were up 15.5% yesterday following the completion of the rolling submission of a biologics license application (“BLA”) to the FDA seeking approval for its AAV ...
Helius Medical Technologies, Inc. announced positive outcomes from its Portable Neuromodulation Stimulator (PoNS) Stroke Registrational Program (SRP), which supports a planned FDA submission for ...
Precigen, Inc. (NASDAQ:PGEN) shares are trading higher on Monday after the company completed the rolling submission for a biologics license application to the FDA for PRGN-2012 (zopapogene imadenovec) ...
ALISO VIEJO, Calif.--(BUSINESS WIRE)--Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal ...
NOVATO, Calif., Dec. 30, 2025 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (RARE) today announced that it has completed the rolling submission of its Biologics License Application (BLA) to the U ...
Please provide your email address to receive an email when new articles are posted on . Following two successful phase 3 studies, Neurotech is preparing to submit a license application for NT-501 to ...
For some people, receiving therapy more frequently over a shorter period can lead to faster relief, better engagement, and ...
The field of biomaterials science is undergoing a revolutionary transformation driven by advances in material design, nanotechnology, and biomedical ...
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