Summit Therapeutics reports that its investigational bispecific antibody ivonescimab, when combined with chemotherapy, significantly reduced the risk ...
FDA approves a new indication for Novo Nordisks Rybelsus (oral semaglutide) tablets to reduce the risk of major adverse cardiovascular events in adult...
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...
