Federal Register notice: FDA extends the comment period for the public meeting on Administering the Hatch-Waxman Amendments: Ensuring a Balance Betwee...
FDA releases its latest batch of Warning Letters that includes Firson Co., Nova Homeopathic Therapeutics, Preservation Solutions and Wuxi Medical Inst...
FDA approves GlaxoSmithKlines Trelegy Ellipta COPD product and denies a Boehringer Ingelheim petition seeking to impose conditions on approval of such...
FDAs Oncologic Drug Advisory Committee gives a mixed voted on the benefit-risk profile for Pfizers Sutent (sunitinib) as adjuvant treatment of adult p...
The Post-Finasteride Syndrome Foundation asks FDA to withdraw marketing approval for Mercks Propecia and its generics due to an unacceptable risk/bene...
The Association for Accessible Medicines says an FDA draft guidance on pre-submission correspondence for ANDA priority reviews will discourage priorit...
Continuing FDA safety concerns involving PD-1/PD-L1 inhibitors spread to two Roche clinical trials, placing them on partial clinical hold.
FDA approves a Symbiomix Therapeutics NDA for Solosec (secnidazole) 2g oral granules for treating bacterial vaginosis in adult women.