The European Medicines Agency (EMA) has experienced a turbulent ... is the reliability of long-term planning for initial marketing authorisation applications (MAAs). This has been a recurrent ...

The EMA warns of products being sold as dendritic cell therapies with little evidence, but high health risks, in the European ...

--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Medicines Agency (EMA) has validated for parallel accelerated review the company’s Marketing ...

Gilead Sciences (GILD) said on Friday that the European Commission (EC) granted conditional marketing authorization for ... European Medicines Agency’s (EMA) Committee for Medicinal Products ...

The marketing authorization was granted by the European Commission upon recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA ...

IXCHIQ ® received marketing authorization in Europe for individuals 18 years and older in July 2024 1. The European Commission (EC) will now review the CHMP recommendation, and a decision on the label ...

on top of the ten-year European market exclusivity as an orphan drug if the Marketing Authorization is granted by the EMA. This also confirms the Company’s ability to reach the full patient ...

The marketing authorization was granted by the European Commission upon recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA ...

MaaT Pharma Receives Positive Opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for MaaT013.

The marketing authorization was granted by the European Commission upon recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in January ...