Boehringer & BridgeBio Seek EU Fast-Track Status; Enfortumab Vedotin Reverts To Standard Review
Applications for the accelerated assessment of planned EU marketing applications for two drugs are being considered by the European Medicines Agency.
You may also be interested in...
The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to investigational products from, among others, Janssen, Sanofi, Boehringer Ingelheim and Mirum.
Only three planned marketing authorization applications are known to have been granted accelerated assessment status by the European Medicines Agency between July and October this year.
Janssen says the review at the European Medicines Agency of its marketing authorization application for cilta-cel reverted to standard timelines because the EMA wanted a GMP inspection and provision of a GMP certificate, "which did not allow continuation of the accelerated assessment timetable.”