Former FDA reviewer Sarah McGarry joins consulting firm Greenleaf Health as senior vice president of drug and biological products.
The CDER Office of Prescription Drug Promotion says two Otsuka Rexulti ads contain misleading presentations of the drugs efficacy.
FDA approves an Eli Lilly NDA for Zepbound (tirzepatide) subcutaneous injection for chronic weight management in obese adults who are on a reduced cal...
CBER director Peter Marks and three medical center researchers editorialize on the value of registries to promote convalescent plasma therapy in the n...
Organon says it agrees with an FDA policy change to have a biosimilar statement accompany both biosimilars and interchangeables.
Reps. Marie Gluesenkamp Perez (D-WA), Sean Casten (D-IL), and Gerry Connolly (D-VA) introduce a bill to ban brand companies from entering into pay-for...
Federal Register notice: FDA makes available a guidance entitled Real-Time Oncology Review (RTOR).
FDA releases the form FDA-483 with 14 observations from an inspection at the Kilitch Healthcare India sterile drug manufacturing facility in Maharasht...
