The CHMP has specifically backed Leqembi to treat mild cognitive impairment or mild dementia from Alzheimer’s but only for patients carrying one or no copy of the ApoE4 gene.

Eisai (ESAIY) and Biogen (BIIB) announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, has reaffirmed its positive opinion by consensus for ...

Novartis NVS announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency has adopted a positive opinion for the label expansion of Fabhalta ...

Krystal Biotech KRYS announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Vyjuvek ...

The commission last month asked the CHMP to consider whether the new information would require an update of the positive opinion, and to consider whether the wording of the risk minimization ...

The North Chicago, Ill., biopharmaceutical company said the European Commission, which generally follows the CHMP's advice, is expected to make a final decision in the first half of the year.

AbbVie (ABBV) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted an opinion recommending the approval of upadacitinib for the treatment of ...

STOCKHOLM, Feb. 28, 2025 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced today that the Committee for Medicinal Products for Human Use (CHMP ...

The Indianapolis drugmaker said the European Commission, which generally follows the CHMP's advice, is expected to make a final decision in the next one to two months. Eli Lilly previously won ...