FDA accepts for priority review an Amgen BLA for tarlatamab for treating certain adult patients with advanced small cell lung cancer.
AdvaMed faults FDA for not approving an extension to the comment deadline on three 510(k) guidances issued in September concerning the 2018 Medical De...
Syndax Pharmaceuticals plans an NDA submission by year end for revumenib, a first-in-class menin inhibitor for treating patients with relapsed/refract...
Federal Register notice: FDA posts a summary of the comments received for the Methodological Challenges Related to Patient Experience Data; Request fo...
The U.S. Supreme Court agrees to hear arguments in an appeal of the 5th Circuit Court of Appeals decision that places restrictions on the chemical abo...
MAPS Public Benefit Corp. files what it calls the first NDA submission for a psychedelic-assisted therapy, MDMA (midomafetamine capsules), for use in ...
FDA says it is creating a nine-member Genetic Metabolic Diseases Advisory Committee.
Public Citizen calls on FDA to strengthen the Botox Boxed Warning to highlight the risk of systemic iatrogenic botulism and related symptoms.
