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 ...

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

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

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

EMA committee recommends approval of AstraZeneca’s Calquence plus chemoimmunotherapy to treat adult patients with mantle cell lymphoma: Cambridge, UK Tuesday, April 1, 2025, 17: ...

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 ...

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.

EMA committee recommends approval of Bristol Myers Squibb’s subcutaneous formulation of Opdivo across multiple solid tumour indications: Princeton, New Jersey Monday, March 31, ...

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

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