“We are very pleased with the productive dialogue with the EMA Pediatric Committee and the positive PIP opinion. This approval marks a major regulatory milestone towards the submission of our ...

They consider the FDA compared with the EMA in this ... despite a positive CHMP opinion. This may indicate the applicant's belief that the drug would not ultimately be approved by the EC.

Novartis (NVS) announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, has adopted a positive opinion and recommended granting a marketing a ...

has announced that its partner Lundbeck has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending marketing ...

The CHMP positive opinion follows four regulatory approvals in the U.S 6., Europe 7, Canada 8 and the UK 9 in adults 18 years of age and older. Valneva expects to receive marketing approval in Brazil ...

today announced that the European Commission has provided a positive opinion from the European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) for OCU410 and OCU410ST Advanced ...

Regeneron Pharmaceuticals, Inc. REGN obtained positive opinion for its pipeline candidate linvoseltamab from the European Medicines Agency’s (EMA ... A potential approval will diversify REGN ...

Krystal Biotech, Inc. announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive recommendation ... option. If approved, VYJUVEK will ...

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