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 ...

Bristol Myers Squibb said a key European regulatory committee is backing a formulation of its blockbuster cancer drug Opdivo that can be injected under the skin.

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 ...

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

The benefits of naltrexone/bupropion (Mysimba) continue to outweigh its risks, despite ongoing uncertainty about long-term ...

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 ...

Bristol Myers Squibb Receives Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo® (nivolumab) Across Multiple Solid Tumor Indications ...

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

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 ...