Bristol Myers BMY announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has recommended approval of Opdivo (nivolumab) for another ...

Vertex Pharmaceuticals VRTX announced that the European Commission (EC) has expanded the label of its blockbuster cystic ...

Eisai (TYO: 4523) and Biogen (Nasdaq: BIIB) today provided an update on the ongoing regulatory review of the Marketing ...

Accord received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for ...

Like lecanemab before it, donanemab’s path to market has been slow and rocky. In the U.S., the antibody received Food and ...

Therapeutics announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a ...

Bristol Myers Squibb (BMS) has announced that its Opdivo (nivolumab) perioperative treatment regimen has been recommended by the European Medicines Agency’s human medicines committee for adults with ...

BeiGene (ONC) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion ...

The agency’s Committee for Medicinal Products for Human Use said Lilly can ask for a re-examination of its opinion. Lilly said Friday that it hopes discussions about the drug continue with the ...

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is ...

The agency’s Committee for Medicinal Products for Human Use said Lilly can ask for a re-examination of its opinion. Lilly said Friday that it hopes discussions about the drug continue with the ...