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...
FDA approves a Meitheal Pharmaceuticals NDA for Contepo (fosfomycin) for injection for treating adults with complicated urinary tract infections.
Aurinia Pharmaceuticals lawsuit against CDER director George Tidmarsh includes screenshots of troubling text messages and emails from Tidmarsh to Kevi...
CDER director George Tidmarsh resigns after being placed on administrative leave amid an internal ethics investigation and a defamation lawsuit tied t...
