The Marketing Authorisation Application comes after the EMA granted talquetamab accelerated assessment in November 2022. This reduces the timeframe for the MAA to be reviewed.

--(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 ...

The EMA previously granted orphan designation ... and New Zealand, including a marketing authorization application; the potential market opportunity for mavorixafor; the anticipated strategic ...

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 ...

Dendreon Pharmaceuticals used to make the only EMA-approved dendritic cell therapy called Provenge (sipuleucel-T), which ...

This approval marks a major regulatory milestone towards the submission of our Marketing Authorization dossier with the EMA,” said Gianfranco Pittari, MD, PhD, Chief Medical Officer at MaaT Pharma.

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 ...

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