FDA approves a Sage Chemical ANDA for the first generic version of Mylans Apokyn (apomorphine hydrochloride injection) drug cartridges to treat hypomo...
Speakers at a Friends of Cancer Research program on diagnostic tests push the VALID Act and the need for an FDA framework for regulating the tests.
FDA extends by three months its review of a Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide) for treating obesity and control of h...
Federal Register notice: FDA seeks comments on an information collection extension entitled Exemptions From Substantial Equivalence Requirements for T...
FDA says GSK/Virs sotrovimab should not be used in geographic areas where Covid infection is likely to have been caused by a non-susceptible variant.
FDA says an Arrow International recall of its Arrow-Trerotola percutaneous thrombolytic device is Class 1.
FDA grants Boehringer Ingelheim Pharmaceuticals a breakthrough therapy designation for its investigational therapy BI 1015550 and its use in treating ...
Apricus Biosciences says it cant afford to do what FDA says is needed for a Vitaros NDA resubmission and it is shopping the U.S. rights to the erectil...