Apellis has said it will seek a re-examination of the CHMP’s opinion, noting that there were “multiple dissenting voices” by members of the panel. It also said that specialists at an ad hoc ...

Eli Lilly, which is seeking European approval of Kisunla for the treatment of early symptomatic Alzheimer's, said it will seek re-examination by CHMP. The Indianapolis drugmaker said it remains ...

The CHMP’s favorable opinion supports the administration ... The decision will apply to all EU member states, as well as ...

The committee based its decision on data showing the subcutaneous formulation of Opdivo was not inferior to the intravenous formulation.

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 ...