FDA asks the Allergenic Products Advisory Committee to comment on whether efficacy and safety data support approval of Aimmune Therapeutics Palforzia ...
Federal Register notice: FDA determines that Sanofi Aventis Calcimar (calcitonin salmon) injection, 200 IU/mL was not withdrawn from sale due to safet...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Tsunami MedTechs Aegea Vapor System, indicated ...
Four stakeholders suggest changes to an FDA draft guidance on the format and content of instructions for use information for drugs, biologics, and com...
Federal Register notice: FDA requests comments on 21 drug substances concerning abuse potential, actual abuse, medical usefulness, trafficking, and im...
Ultragenyx and Kyowa Kirin say they will submit an sBLA for a new indication for their Crysvita in the first half of 2020.
A Reuters investigative report examines the way in which a federal court allowed Merck to keep some Propecia risk information secret during considerat...
Hospira recalls one lot of its bacteriostatic water for injection, USP, 30 mL, multi-dose vial due to sterilization concerns.