New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, including BioCryst's Orladeyo for the routine prevention of recurrent attacks of hereditary angioedema.
You may also be interested in...
The Philippines regulator has issued more guidance for companies that want to use its registration pathways for products that are already approved in other countries.
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.
In contrast with the five COVID-19 vaccines that are approved in the EU under conditional marketing authorizations, the European Medicines Agency has recommended that Valneva’s vaccine receive a standard approval.