Citing time restrictions, FDA denies without comment a US WorldMeds petition asking for specific treatment of any ANDA citing its Apokyn.
FDA orders a fertility clinic in San Juan, Puerto Rico, to cease manufacturing due to significant violations of agency regulations.
Evofem Biosciences resubmits its NDA for Amphora (L-lactic acid, citric acid and potassium bitartrate), a multipurpose vaginal pH regulator for preven...
The Justice Department says an advance practice nurse who worked in a pain clinic was sentenced to three years of probation for accepting kickbacks fr...
Former FDA commissioner Frank Young dies at age 88.
FDA warns Lohxa LLC about CGMP violations in its production of finished pharmaceuticals.
A Center for Disease Control and Prevention report says that healthcare-associated infections resulting from medical devices are more likely to be ant...
CymaBay Therapeutics terminates a Phase 2b study of seladelpar in subjects with non-alcoholic steatohepatitis and its recently initiated Phase 2 study...