[ Price : $8.95]
Roivants Kinevant Sciences unit halts the development of namilumab for treating sarcoidosis after a Phase 2 study failed to show t...[ Price : $8.95]
FDA issues a report and plan on best practices for guidances, incorporating comments from a 2023 draft report and plan.[ Price : $8.95]
FDA publishes a guidance with recommendations for marketing submissions for Predetermined Change Control Plans for artificial inte...[ Price : $8.95]
FDA warns South Koreas LCC Ltd. about CGMP violations in its manufacturing of unapproved and misbranded over-the-counter drugs.[ Price : $8.95]
FDA grants Merck a breakthrough therapy designation for sacituzumab tirumotecan (sac-TMT) and its use in treating certain patients...[ Price : $8.95]
The House Select Subcommittee on the Coronavirus Pandemic faults many FDA actions and decisions in its 550-page report on lessons ...[ Price : $8.95]
FDA warns New York, NY-based Applied Therapeutics about violations in its conduct of a clinical trial.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Use of Circulating Tumor DNA for Curative-Intent Solid Tumo...