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

“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 ...

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

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 ...

of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorization of a label extension for IXCHIQ ®, Valneva's single-dose vaccine for the prevention of disease ...

Therefore, this positive CHMP opinion marks a crucial milestone toward introducing a more robust preventative solution against chikungunya in the EU. Broader accessibility will help provide ...

AbbVie announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of upadacitinib (Rinvoq; 15 mg, once ...

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 ...

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 ...