FDA Establishes Regulatory Review Period for Kebilidi
February 13, 2026
February 13, 2026
WASHINGTON, Feb. 13 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration announced the determination of the regulatory review period for the human biological product Kebilidi. This notice follows the submission of patent term restoration applications to the U.S. Department of Commerce Patent and Trademark Office by National Taiwan University.
Kebilidi is a gene therapy indicated for adult and pediatric patients with aromatic L-amino acid decarboxy . . .
Kebilidi is a gene therapy indicated for adult and pediatric patients with aromatic L-amino acid decarboxy . . .