Kenvue urges FDA to deny a recent citizen petition requesting updates to the pregnancy warning on acetaminophen products.
A new report by RBC Capital Markets finds a slowdown in FDA drug approvals, a rise in rejected applications, and an increase in delayed reviews during...
FDA approves expanded indications for Celltrions Yuflyma (adalimumab-aaty) to include treating hidradenitis suppurativa in adolescent patients aged 12...
FDA names the first nine voucher recipients under the recently launched Commissioners National Priority Voucher pilot review program.
FDA approves Azurity Pharmaceuticals Ferabright (ferumoxytol injection), an iron-based contrast agent for magnetic resonance imaging of the brain in a...
Sen. Jim Banks (R-IN) urges FDA to step up inspections of pharmaceutical manufacturing facilities abroad, citing persistent quality lapses and lagging...
Attorneys from Mintz warn that FDAs recent safety communication on acetaminophen and autism may signal a departure from long-standing procedures for d...
FDA accepts for priority review a Johnson & Johnson supplemental NDA for Akeega (niraparib and abiraterone acetate dual-action tablet) plus prednisone...
