An appeals court appears to have raised the bar for generic drugmakers seeking to preserve 180-day marketing exclusivity after missing its FDA-mandate...
FDA and the International Coalition of Medicines Regulatory Authorities complete an assessment of a new biologics testing approach that could reduce u...
Researchers say clear rules are needed for when FDA decides to publicly release complete response letters.
FDA issues an Early Alert after becoming aware that Boston Scientific sent a letter to customers recommending all Imager II Angiographic Catheters be ...
FDA approves Eli Lillys Mounjaro (tirzepatide) for lowering the risk of major adverse cardiovascular events.
FDA approves updated Covid-19 vaccines from Moderna, Pfizer-BioNTech and Novavax/Sanofi for the upcoming vaccination season.
FDA issues Alar Pharmaceuticals an untitled letter over promotional materials for its investigational ketamine drug, ALA-3000, because they improperly...
FDAs approval of new drugs is increasingly being supported by fewer clinical studies.
