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FDA warns Indias Indoco Remedies about repeat CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA publishes a draft guidance with recommendations on clinical trials for drugs and biologics to treat obesity and overweight.[ Price : $8.95]
FDA issues a guidance finalizing a 2023 draft document on communicating scientific information on unapproved uses of approved or c...[ Price : $8.95]
Johnson & Johnson says its Phase 3 MARIPOSA study showed that its Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) had a st...[ Price : $8.95]
Federal Register notice: FDA corrects a 12/5/2024 debarment notice against Yong Sheng Jiao (also known as Yongsheng Jiao and Wilso...[ Price : $8.95]
Denali Therapeutics and Calico Life Sciences say their two eukaryotic initiation factor 2B activator drugs each failed to meet pri...[ Price : $8.95]
FDA publishes a draft guidance with recommendations on lifecycle management and marketing submissions for AI-enabled medical devic...[ Price : $8.95]
FDA publishes a draft guidance intended to improve the representation of females in medical product clinical trials.