EMA OKs First Drug To Prevent RSV Infection In Babies
Takeda Pulls EU Filing For Exkivity To Prevent CHMP Rejection
A new medicine to protect newborns and infants from RSV infection and a new treatment for DLBCL are among a dozen drugs that have been recommended for pan-EU approval.
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
Its crunch time for sponsors of more than a dozen products as the EMA meets to adopt opinions on several marketing authorization applications.
The sponsors of six drugs that are nearing the end of the regulatory review cycle in the EU could this week be asked to explain why the European Medicines Agency should recommend approving their products.