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.

The European Commission (EC) will now review the CHMP recommendation, and a decision on the label extension application of IXCHIQ ® in the European Union (EU), Norway, Liechtenstein and Iceland is ...

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 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 ...

The CHMP's positive opinion includes support for administration ... VYJUVEK was designed to treat DEB at the molecular level by providing the patient's skin cells the template to make normal COL7 ...

(RTTNews) - Regeneron Pharmaceuticals (REGN) announced the CHMP has adopted a positive opinion recommending conditional marketing authorization of linvoseltamab to treat adults with relapsed and ...

Therefore, this positive CHMP opinion marks a crucial milestone toward introducing a more robust preventative solution against chikungunya in the EU. Broader accessibility will help provide ...

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.

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 CHMP’s positive opinion includes support for administration ... VYJUVEK was designed to treat DEB at the molecular level by providing the patient’s skin cells the template to make normal COL7 ...