“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 ...

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 ...

Krystal Biotech's VYJUVEK, a first-mover gene therapy for DEB, has received a positive CHMP recommendation. Read why KRYS ...

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 ...

The European Medicines Agency (EMA) has agreed to review GSK’s application of expanding Nucala’s (mepolizumab) use as add-on ...

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