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 ...

Pfizer PFE announced that the European Commission (“EC”) has granted marketing authorization to expand the use of its RSV ...

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 ...

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.

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

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

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

Halozyme Therapeutics (HALO) announced that Bristol Myers Squibb (BMY) received a positive opinion from the Committee for Medicinal Products ...

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

European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended against a marketing authorization for the drug’s use in early symptomatic Alzheimer’s disease.

AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been recommended for approval in the European Union (EU) for the treatment of adult patients with previously ...