The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of ...

CHMP recommends approval of Regeneron's Lynozyfic, Krystal's Vyjuvek, Accord's trabectedin, Takeda's Deqsiga, and 16 label ...

The CHMP was also not convinced about the efficacy ... The companies say they are planning to submit a written notice to the regulatory agency, requesting a re-evaluation of Evenity for the ...

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 ...

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 ...

Pharmaceuticals announced that the European Medicines Agency’s, EMA, Committee for Medicinal Products for Human Use, CHMP, has ...

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.

(RTTNews) - AstraZeneca (AZN.L, AZN) announced Imfinzi was recommended for approval in the European Union by CHMP as first and only immunotherapy for limited-stage small cell lung cancer.

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.

Europe’s drug regulatory agency has given Kizfizo a negative opinion for the second time, following one from November 2024.

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 ...