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

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

The European Medicines Agency’s (EMA) human medicines committee has recommended Krystal Biotech’s Vyjuvek (beremagene ...

Eisai (ESAIY) and Biogen (BIIB) announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, ...

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 measures ...

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.

BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has reaffirmed its ...

Vertex Pharmaceuticals (VRTX) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted an opinion ...

Approximately one to two people per million worldwide are diagnosed with the ultra-rare kidney disease every year ...

Orphelia Pharma is exploring alternative regulatory pathways for KIZFIZO after receiving a negative opinion from the ...

The CHMP’s positive opinion includes support for administration of VYJUVEK in either a health care setting (e.g., a clinic) or at home. If deemed appropriate by a healthcare professional ...

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of AbbVie's upadacitinib (Rinvoq) to treat adults with giant cell arteritis (GCA).