So for the FDA, the time of approval as the endpoint for market authorization is appropriate. In Europe, the EMA's process involves one more step, creating an intermediate time point that seems to ...

In October, the EMA announced that it was looking to improve the efficiency of its approval process for new medicines in the European Union (EU). The stated aim for the agency was to better manage ...

Telethon has submitted a marketing authorisation application (MAA) to the European Medicine’s Agency (EMA) for evaluating ...

If approved by the EMA, this new option could streamline the vaccination process in clinical settings across Europe. GSK is a global biopharma company focused on uniting science, technology ...

uncertainties inherent in the regulatory approval process could impact the timing, progress, and outcome of the EMA’s review; potential delays or difficulties in commercializing mavorixafor in ...

uncertainties inherent in the regulatory approval process could impact the timing, progress, and outcome of the EMA’s review; potential delays or difficulties in commercializing mavorixafor in ...

The Montreal-based C3i Center obtained regulatory approval from the European Medicine Agency (EMA) to produce cell therapy therapies for the European market. The company obtained a certificate of ...

This approval marks a major regulatory milestone ... The PDCO issues an opinion on PIP as part of the regulatory process and the EMA adopts a final decision based on the PDCO's opinion.