Most Recent Articles by Lea Eslava-Kim, PharmD
The FDA has granted Priority Review to the New Drug Application (NDA) of tezacaftor/ivacaftor (Vertex) for the treatment of patients ≥12yrs old with cystic fibrosis (CF) who have two copies of the F508del mutation or one F508del mutation and one residual function mutation.
The FDA has accepted and granted Priority Review to the Biologics License Application (BLA) of emicizumab (Genentech) for the prophylactic treatment of hemophilia A in adults, adolescents and children with factor VIII inhibitors.
The FDA has accepted for review the BLA resubmission for AndexXa (andexanet alfa; Portola) for the reversal of the anticoagulant effects of Factor Xa inhibitors in patients experiencing uncontrolled or life-threatening bleeding.
Amgen announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for erenumab for the prevention of migraines.
The Food and Drug Administration (FDA) has granted Fast Track designation to SAGE-217 (Sage Therapeutics) for the potential treatment of major depressive disorder (MDD).