Novartis AG
remibrutinib
chronic spontaneous urticaria (CSU)
Date
TBD
Advisory committee Β· Date TBD estimated
What's at stake
An FDA advisory committee reviews remibrutinib for chronic spontaneous urticaria (CSU) around Date TBD. The panel's public vote often front-runs the agency's final verdict β and the share price.
Primary source
Β· SEC 6-K
verified 13h ago
βEMAβs CHMP adopted a positive opinion recommending marketing authorization for remibrutinib as an oral treatment for chronic spontaneous urticaria (CSU) in adults with an inadequate response to H1-antihistamine therapy.β