A FibroGen Phase 3 study of its anemia drug roxadustat fails to meet its primary efficacy endpoint.
FDA issues Ajinomoto Bio-Pharma Services a three-item Form FDA-483 after inspecting the firm in January.
A citizen petition from PhRMA and other groups urges FDA to not approve a proposal from Colorados Department of Health Care Policy & Financing that se...
FDA reviewers question the reliability of an actual use study that was submitted to support approval of a Laboratoire HRA Pharma NDA seeking a prescri...
FDA accepts for review a Glaukos NDA for iDose TR (travoprost intraocular implant) for treating open-angle glaucoma or ocular hypertension.
Federal Register notice: FDA determines that Bayers Levitra (vardenafil HCl) oral tablets (5mg, 10mg and 20mg) were not withdrawn from sale due to saf...
Federal Register notice: FDA makes available a draft guidance entitled Decentralized Clinical Trials (DCT) for Drugs, Biological Products, and Devices...
Alleging weak evidence of effectiveness accepted by an advisory committee, Public Citizen calls on FDA to reject an Otsuka/Lundbeck sNDA for Rexulti t...
