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 ...

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

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

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 ...

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

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 ...

Regeneron on Friday said the recommendation covers adults with adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor, ...

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

Columvi plus chemotherapy showed a 41% reduction in the risk of death in the pivotal phase III STARGLO study 1,2 ; DLBCL-an ...

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).