FDA approves a Foundation Medicine blood-based companion diagnostic for Genentechs cancer drug Rozlytrek.
Public Citizen calls on FDA to postpone a 1/6-expected accelerated approval decision on a Biogen/Eisai Alzheimers drug until after an advisory committ...
The Biotechnology Innovation Organization suggests modifications to an FDA draft guidance on measuring growth and evaluating pubertal development in p...
FDA accepts for review an AstraZeneca BLA for nirsevimab for preventing respiratory syncytial virus lower respiratory tract disease in newborns and in...
FDA publishes three Federal Register notices on device classifications related to de novo requests.
FDA says Lupin recalled one lot of 20 mg Quinapril tablets and three lots of 40 mg tablets due to the potential presence of N-Nitroso-Quinapril, a nit...
FDA approves the first injectable pentosan product for use in horses with osteoarthritis.
Washington Legal Foundation asks the Supreme Court to reverse a California appeals court decision that hit Ethicon with $300 million in civil penaltie...