HANSIZHUANG ® (serplulimab) was the first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of ES-SCLC – ...

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

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

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 ...

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 ...

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

The European Medicines Agency’s (EMA) advisory committee the CHMP has adopted a positive opinion for a label update of Danish ...

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 ...

Janssen-Cilag International NV, a Johnson & Johnson company, announced the CHMP of the European Medicines Agency has recommended the ...

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

OPUVIZ™, a biosimilar referencing Eylea1 (aflibercept), is Samsung Bioepis and Biogen’s second ophthalmology biosimilar to be recommended for marketing authorization by the European Medicines Agency ...

The EMA's Committee for Human Medicinal Products (CHMP) has elected Bruno Sepodes as its new chair for a three-year term. Sepodes, senior expert at INFARMED, has been with EMA since 2005, holding vari ...