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 ...

The Committee for Medicinal Products for Human Use (CHMP) has recommended that the topical gene therapy be approved to treat wounds in DEB patients of all ages in either a healthcare setting or at ...

1 "The CHMP's positive opinion for upadacitinib for adults living with giant cell arteritis is an important step toward our goal of improving outcomes for patients suffering with this disease ...

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 Committee for Medicinal Products for Human Use (CHMP) has also recommended J&J’s Stelara (ustekinumab) to treat paediatric patients weighing at least 40kg with moderately to severely active CD, ...

Novartis (NVS) announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, has adopted a positive opinion and recommended granting a marketing a ...

Neuraxpharm and partner Minoryx Therapeutics, meanwhile, were unable to convince the CHMP that they should get conditional approval for PPAR gamma agonist Nezglyal (leriglitazone) as a treatment ...

The Pittsburgh biotechnology company said it expects a final decision from the European Commission, which generally follows the CHMP's advice, in the second quarter. Krystal, which won U.S. Food ...

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 ...