Fears of heightened scrutiny by the FDA will be calmed by a look at historic rates of complete response letters.
March will see big US decisions for Evrenzo and ide-cel, while tanezumab goes in front of an advisory committee.
The US regulator will provide verdicts on cancer projects from TG and Athenex, while Sarepta aims for its third Duchenne approval.
The FDA will have a busy November, with decisions due for Bristol, Sanofi and Y-mabs, among others.
Abbvie’s bid for Allergan shows that the Botox franchise is impenetrable. The market agrees.