A STAT report highlighted in Medpage says CBER employees are concerned about the environment established by their new director, Vinay Prasad.
FDA issues Biohaven a complete response letter, rejecting the companys NDA for Vyglxia (troriluzole) as a treatment for spinocerebellar ataxia.
An Axios report following the resignation of CDER director George Tidmarsh questions how much more agency dysfunction industry can accept before simpl...
Sarepta Therapeutics reports mixed data from its Phase 3 ESSENCE confirmatory study evaluating its Duchenne muscular dystrophy drugs Amondys 45 (casim...
Compass Pathways says it expects to be able to launch its COMP360 psilocybin treatment for treatment-resistant depression nine to 12 months sooner tha...
Otsuka ICU Medical recalls (Class 1) one lot of its potassium chloride injection, 20 mEq, after discovering that the overwrap label was incorrectly pr...
FDA gives investigative device exemption approval for an Aqua Medical pilot clinical trial of its Proximal Intestinal Mucosal Ablation system to treat...
A new report from the Reagan-Udall Foundation calls for broad operational and policy reforms to improve the efficiency, representativeness, and succes...
