CDER missed six goal dates among its 2023 novel approvals, reflecting safety concerns as well as pandemic-related inspection delays; Duchenne muscular dystrophy accelerated approval disagreements caused the biologics center’s lone missed goal.
Possibly the most surprising aspect of the US FDA’s novel approvals in 2023 is a steep jump in what has been one of the most stable review metrics for more than a decade: how many times the FDA missed Prescription Drug User Fee Act user fee goal dates for novel approvals.
The Center for Drug Evaluation and Research approved six novel agents after their user fee goal dates had passed, representing...
If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.
Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.
