FDA sends Provention Bio a complete response letter on its BLA for teplizumab and its use for delaying clinical Type 1 diabetes in at-risk individuals...
CDER director Patrizia Cavazzoni appoints Jacqueline Corrigan-Curay as principal deputy Center director.
FDA tells Soleno Therapeutics that an additional clinical trial is necessary before the company submits an NDA for once-daily DCCR (diazoxide choline...
FDA acting commissioner Janet Woodcock says the agency FY 2022 budget request envisions significant efforts at data modernization and enhanced technol...
The DC Court of Appeals says FDA cannot ban the use of electrical stimulation devices to treat aggressive or self-injurious behavior.
CDER Division of Therapeutic Proteins director Amy Rosenberg leaves the agency to join EpiVax as senior director of immunology and protein therapeutic...
A report on FDAs use of patient-focused drug development calls on the agency to do more to promote such development.
FDA warns Aquavit Pharmaceuticals it is marketing unapproved medical devices.