The Prescription Drug User Fee Act (PDUFA) target action date is May 10, 2023PRINCETON, N.J. & DEERFIELD, Ill. (BUSINESS WIRE) Otsuka Pharmaceutical Development & Commercialization, Inc., (Otsuka) and Lundbeck Pharmaceuticals LLC (Lundbeck) announce the Joint Meeting of the Psychopharmacologic Drugs Advisory C.
Operator: Greetings and welcome to the IntelGenx Fourth Quarter and Full Year 2022 Financial Results Conference Call. At this time all participants are in listen-only mode.
Spherix Global Insights estimates that SER-109 (Seres Therapeutics; Aimmune) will be able to challenge fecal microbiota, live-jslm in C. difficile treatment.
Digital health data can facilitate the participation of underrepresented and diverse patient populations in clinical trials, but first the FDA must build its capability to evaluate such information in its regulatory processes for new drug development.