The U.S. FDA approved 17 drugs in July, down from 23 in June, bringing the year-to-date total to 125. Through July, 2025 remains the third-highest count in BioWorld’s records, trailing 135 approvals in 2024 and 126 in 2020.
The U.S. FDA approved 17 drugs in July, down from 23 in June, bringing the year-to-date total to 125. Through July, 2025 remains the third-highest count in BioWorld’s records, trailing 135 approvals in 2024 and 126 in 2020.
It looks like Biogen Inc.’s Nrf2 activator, Skyclarys (omaveloxolone), will maintain its status as the sole therapy approved for treating patients with Friedreich’s ataxia (FA), at least for now. The U.S. FDA asked for another “adequate and well-controlled study” in the complete response letter (CRL) issued to PTC Therapeutics Inc. for 15-lipoxygenase inhibitor vatiquinone. The agency said “substantial evidence of efficacy was not demonstrated.”
PTC Therapeutics Inc. will be launching its oral phenylketonuria therapy, Sephience (sepiapterin) in both the U.S. and Europe this summer, following the U.S. FDA approval just ahead of its July 29 PDUFA date. Sephience previously gained marketing authorization by the European Commission, roughly three months after a thumbs up from the EMA’s Committee for Medicinal Products for Human Use.
