EU Accelerated Assessment Tracker
Fast-Track Success For Janssen-Cilag’s Teclistamab
Janssen-Cilag's EU filing for teclistamab is being reviewed under the European Medicines Agency’s accelerated assessment procedure. The outcome of Sanofi’s request relating to nirsevimab is not yet in the public domain.
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New EU Filings Include Tibsovo Resubmission, Pegunigalsidase & Daprodustat
Servier is trying again with Tibsovo in the EU, while Protalix is using June 2021 data to support its filing for pegunigalsidase, which the US regulator turned down last April.
AZ Secures EU Fast-Tack Review For Nirsevimab
There could be a regulatory decision on AstraZeneca and Sanofi's nirsevimab in the EU in H2 as a result of the European Medicines Agency speeding up its review of the marketing application for the potential new immunization against RSV in all infants.
New EU Filings
Teclistamab, Janssen’s bispecific antibody for treating multiple myeloma, is among the latest new medicines that have been submitted for review for potential pan-EU approval.