Go or no go? Bristol’s Tyk2 test
A green light from the FDA is expected for deucravacitinib, while Amylyx, Ferring and Oncopeptides head for panels.
Regulatory rejection flurry does not make a storm
Fears of heightened scrutiny by the FDA will be calmed by a look at historic rates of complete response letters.
Go or no go? A delayed decision on Evrenzo
March will see big US decisions for Evrenzo and ide-cel, while tanezumab goes in front of an advisory committee.
Go or no go? Oncology decisions ahead for the FDA
The US regulator will provide verdicts on cancer projects from TG and Athenex, while Sarepta aims for its third Duchenne approval.
Go or no go? Big decisions loom for Bristol and Sanofi
The FDA will have a busy November, with decisions due for Bristol, Sanofi and Y-mabs, among others.