Posted by Michael Wonder on 12 Sep 2022
Chiesi Global Rare Diseases announces FDA acceptance of BLA filing for velmanase alfa for the proposed treatment of alfa mannosidosis
12 September 2022 - FDA grants priority review designation with PDUFA date in the first half of 2023.
Chiesi Global Rare Diseases announced today that the US FDA has accepted the biologics license application and granted priority review designation for velmanase alfa, the company's investigational enzyme replacement therapy for the proposed treatment of alfa mannosidosis.
