FDA accepts for priority review a Dizal NDA for sunvozertinib, an oral EGFR inhibitor for treating locally advanced or metastatic non-small cell lung ...
FDA warns Indias Indoco Remedies about repeat CGMP violations in its production of finished drugs.
FDA publishes a draft guidance with recommendations on clinical trials for drugs and biologics to treat obesity and overweight.
FDA issues a guidance finalizing a 2023 draft document on communicating scientific information on unapproved uses of approved or cleared medical produ...
Johnson & Johnson says its Phase 3 MARIPOSA study showed that its Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) had a statistically signific...
Federal Register notice: FDA corrects a 12/5/2024 debarment notice against Yong Sheng Jiao (also known as Yongsheng Jiao and Wilson Jiao).
Denali Therapeutics and Calico Life Sciences say their two eukaryotic initiation factor 2B activator drugs each failed to meet primary and secondary e...
FDA publishes a draft guidance with recommendations on lifecycle management and marketing submissions for AI-enabled medical device software functions...