The US Food and Drug Administration (FDA) has accepted for filing Krystal Biotech’s (NASDAQ: KRYS) Biologics License Application (BLA) for its lead candidate B-VEC in the treatment of patients with dystrophic epidermolysis bullosa (DEB).
FDA granted Priority Review designation
PDUFA target action date is February 17, 2023
FDA stated that it is not currently planning to hold an advisory committee meeting
The United States Food and Drug Administration (FDA) has accepted Krystal Biotech’ (NASDAQ: KRYS) Investigational New Drug (IND) application to evaluate KB407 in a clinical trial for cystic fibrosis (CF).