Posted by Michael Wonder on 28 May 2026
Beren Therapeutics announces FDA extension of review period for new drug application for adrabetadex for the treatment of infantile-onset Niemann-Pick disease, type C
28 May 2026 - Beren Therapeutics announced that the US FDA has extended by three months the review timeline of its new drug application for adrabetadex for the treatment of infantile-onset Niemann-Pick disease, type C.
The new PDUFA target action date is 17 November 2026.
