New EU Filings
Executive Summary
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.
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EU Accelerated Assessment Tracker
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.
Parsaclisib & Sirolimus Gel Filed In EU For Rare Diseases
Incyte’s next-generation PI3K-delta inhibitor, parsaclisib, and Nobelpharma’s topical sirolimus gel are among the latest marketing authorization applications that have been filed in the EU.
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.