Federal Register notice: FDA makes available a final guidance entitled Clinical Pharmacology Considerations for the Development of Oligonucleotide The...
Takeda says data from its SKYLINE and SKYWAY studies of soticlestat (TAK-935) in Dravet syndrome and Lennox-Gastaut syndrome patients failed to meet t...
FDA issues a partial clinical hold on a BioNTech/Medilink Therapeutics Phase 1 clinical (NCT05653752) trial that is evaluating BNT326/YL202 in certain...
FDA approves Mercks Keytruda (pembrolizumab) for use with carboplatin and paclitaxel in adult patients with primary advanced or recurrent endometrial ...
Federal Register notice: FDA makes available a final guidance entitled Diabetic Foot Infections: Developing Drugs for Treatment.
FDA posts a final guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA that provides information on how the agency intends to assign ...
FDA gives a one-item Form FDA-483 to Chugai Pharma Manufacturing Co. after inspecting the firms Utsunomiya, Tochigi, Japan facility 3/25 to 4/2.
FDA posts a final guidance entitled Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics.
