Obstetricians, gynecologists, other medical professionals, and abortion rights advocates petitioned the U.S. Food and Drug Administration (FDA) on Tuesday to urge Danco Laboratories to seek approval of mifepristone, a pill used in terminating early pregnancies at home, for miscarriage management.
Tag Archive for: Supplemental New Drug Application (sNDA)
Tuesday morning saw the FDA acceptance of a supplemental New Drug Application (sNDA) and supplemental Biologics License Application (sBLA) for three industry powerhouses.
Servier today announced that the U.S. Food and Drug Administration approved TIBSOVO (ivosidenib tablets) in combination with azacitidine for the treatment of patients with newly diagnosed IDH1-mutated acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
