Merck and Eisai say results from the Phase 3 LEAP-015 trial evaluating Keytruda plus Lenvima in gastroesophageal adenocarcinoma patients missed its en...
FDA grants Clarity Pharmaceuticals a fast track designation for 64Cu-SAR-bisPSMA for positron emission tomography imaging prostate cancer lesions in p...
Caranx Medical files a PMA for its TAVIpilot AI Software for real-time intra-operative guidance of transcatheter heart valve implantation.
A bipartisan group of senators reintroduce legislation to mandate the inclusion of drug prices in direct-to-consumer ads.
FDA will review a Biogen sNDA for a Spinraza higher dose regimen.
FDA removes information and documents regarding several diversity-related initiatives and policies, presumably in response to a Trump Administration E...
Former FDA associate commissioner for womens health Susan Wood passes away at her home in London after battling glioblastoma (brain cancer).
FDA extends its review of a Stealth BioTherapeutics NDA for elamipretide, a first-in-class mitochondria-targeted therapeutic for treating Barth syndro...
