Novo Nordisk receives a positive opinion from the CHMP for a label update of Wegovy to reflect reduced heart failure symptoms ...

Amid a parade of regulatory endorsements in Europe, Apellis Pharmaceuticals’ ophthalmology prospect pegcetacoplan has been ...

Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval ...

Apellis Pharmaceuticals, Inc. (APLS) announced on Friday that the Committee for Medicinal Products for Human Use or CHMP of the ...

This CHMP opinion was made despite broad support for pegcetacoplan from the European retina community and multiple dissenting votes by CHMP members who supported a path to approval.” “We have seen the ...

Elahere, which won initial U.S. Food and Drug Administration approval in 2022 for platinum-resistant ovarian cancer, was the key asset in AbbVie's $10.1 billion acquisition of biotech ImmunoGen that ...

With more than 200 mpox-related deaths reported globally, the EMA has approved Imvanex for adolescents aged 12-17 years.

Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of Novo Nordisk A/S’ (NYSE ...

Apellis Pharmaceuticals shares are moving lower after the Committee for Medicinal Products for Human Use of the European Medicines Agency confirmed its June 2024 negative opinion following ...

The EMA has approved Penbraya for protection against invasive meningococcal disease and an update of the composition of two ...

The CHMP initially adopted a negative opinion in January after finding it was unable to establish a positive balance of benefits and risks for Syfovre, but Apellis sought a re-examination and was able ...

Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") today announced that the Committee for Medicinal Products for Human Use ...