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

CHMP recommends approval of Regeneron's Lynozyfic, Krystal's Vyjuvek, Accord's trabectedin, Takeda's Deqsiga, and 16 label ...

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 ...

Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that ...

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

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 ...