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

today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorization of a label extension for ...

today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorization of a label extension ...

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 ...

Recommendation based on the findings from the Phase 3 QUASAR programme in ulcerative colitis 1. Beerse, Belgium (28 February 2025) - Johnson & Johnson today announced that the Com ...

JAK inhibitor Rinvoq (upadacitinib) has been backed by the CHMP as a 15mg, once-daily treatment for adults with GCA, an ...

(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 ...

If granted, IXCHIQ ® will become the first vaccine against the chikungunya virus (CHIKV) available in the EU for adolescents 12 years of age and older The European Commission (EC) will now review the ...

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.