Shots:The US FDA approved 10 NDAs and 3 BLA in August 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 89 novel products in 2023In August 2023, the major highlights drugs were Zurzuvae (zuranolone) approval for women with postpartum depression and Veopoz (pozelimab-bbfg) for children…
Shots:Olivier highlighted the P-II/III data based on which Regeneron’s BLA for Pozelimab was accepted by the US FDA under priority review to treat adults and children with CHAPLE diseaseCHAPLE disease is driven by an overactivation of the complement system due to CD55 deficiency. Pozelimab blocks the activity of complement factor C5 and prevents…

