Shots:
Japan’s MHLW has received NDA for conditional approval of avacincaptad pegol (ACP) to treat geographic atrophy (GA) secondary to AMD
Submission was backed by the P-II/III (GATHER1) & P-III (GATHER2) trials assessing safety & efficacy of ACP (2mg, Q1M, intravitreal) in pts with GA secondary to AMD
Data from both trials showed reduced…
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 2023
In August 2023, the major highlights drugs were Zurzuvae (zuranolone) approval for women with postpartum depression and Veopoz (pozelimab-bbfg) for children…

