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 ...
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 ...
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 ...
In January 2025, as part of its decision-making process, the EC asked the CHMP to consider information on the safety of lecanemab that became available after the adoption of the CHMP opinion in ...
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, ...
Brighton titans Architects make time for every aspect of their sound on epic 11th album, The Sky, The Earth & All Between. And while For Those That Wish To Exist perfectly embodied that bigger and ...
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 ...
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 ...
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 ...
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 ...
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