FDA clears the Siemens Medical Solutions NAEOTOM Alpha improved CT imaging device, described by the agency as the first major CT technology change in ...
CDER drug safety operations (DSO) associate director Terry Toigo retires and, in the interim, DSO senior staff member Amy Ramanadham has been named ac...
The 11th Circuit Court of Appeals tells a Florida federal court it erred in granting summary judgment to FDA and Jacobus over orphan drug exclusivity ...
Bills in the House and Senate would create an emergency supply of active pharmaceutical ingredients needed to make essential generic drugs.
Apellis Pharmaceuticals says it will file an NDA for pegcetacoplan, an investigational, targeted C3 therapy treating geographic atrophy secondary to a...
PharmaTher Holdings retains former CDER antipsychotic guru Thomas Laughren as a regulatory affairs advisor to help a depression therapy.
FDA approves AbbVies novel migraine prevention drug Qulipta.
FDA publishes a draft guidance on investigator responsibilities for safety reporting for INDs and IDEs.