Accelerated Assessment Success In EU For CSL Behring And Roche
EtranaDez Will Be And Mosunetuzumab Already Is On Fast-Track Review Pathway At EMA
There have been some recent successes on the accelerated assessment front in the EU but more requests are rejected than granted.
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The filing for Origin Biosciences’ fosdenopterin (Nulibry) is being fast-tracked at the European Medicines Agency. The outcomes of accelerated assessment requests from Janssen and Sanofi for teclistamab and nirsevimab respectively appear not yet to be in the public domain.
Orphan drugs and COVID-19 products are among the latest filings under review by the European Medicines Agency for potential pan-EU approval.
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.