(RTTNews) - Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European ...

Bristol Myers (BMY) announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has recommended approval of Opdivo plus Yervoy for the ...

Merck (MRK) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use, or CHMP, adopted an opinion recommending approval of Keytruda, Merck’s anti-PD-1 ...

The CHMP in July recommended against approval of Leqembi, citing safety and efficacy issues, but Biogen and Eisai asked the panel to take another look. The companies said the European Commission ...

The European Commission, which generally follows CHMP's advice, will now review the recommendation, with a decision expected by the end of the year. The U.S. Food and Drug Administration approved ...

The Scientific Advisory Group (SAG) has been called in to assist the EMA’s CHMP human medicines committee in its review of the drug, which is vying to become the first disease-modifying therapy ...

If the EMA follows the CHMP’s advice, Zynquista will become the second SGLT-acting drug to be approved for use alongside insulin in type 1 diabetes after AstraZeneca’s SGLT2 inhibitor Forxiga ...

Credit: luchschenF via Shutterstock. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sanofi’s Sarclisa combined with Velcade ...

The European Medicines Agency’s (EMA) human medicines committee (CHMP) made a number of recommendations at its November meeting, notable among which was a reversal of a previous rejection of Alzheimer ...

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, ...