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Uveitis — an inflammation of the middle layer of the eye — in treated patients has prompted FDA to halt enrollment in Nuvation Bio’s phase 1/2 dose-escalation study of NUV-422, a checkpoint inhibitor under investigation for a wide variety of solid tumors. Read More
Study investigators said it is “expected there will be limited [Aduhelm] prescription and usage in routine clinical practice making the study not feasible for enrollment.” Read More
Sarepta Therapeutics has been hit with an FDA clinical hold on its trial of SRP-5051 (vesleteplirsen) for the treatment of Duchenne muscular dystrophy after a trial participant experienced a serious adverse event (SAE) that could have been life-threatening. Read More
At long last, PTC Therapeutics has announced positive results from a study of Translarna (ataluren), the company’s drug for patients with nonsense mutation Duchenne muscular dystrophy. Read More