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 ...

Following a flurry of activity at this month’s meeting of the European Medicines Agency’s Committee for Medicinal Products ...

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: ...

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

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 measures ...

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

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 ...

About Fabhalta® (iptacopan) Fabhalta (iptacopan) is an oral, Factor B inhibitor of the alternative complement pathway 6-7.

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).