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

The Scientific Advisory Group (SAG) has been called in to assist the EMA’s CHMP human medicines committee in its review of the drug, which is vying to become the first disease-modifying therapy ...

leading to a steady overall improvement in patient survival," said the EMA in a statement on the CHMP recommendation. "However, for patients who have already been treated with three major classes ...

BREYANZI has significant market potential due to its innovative approach as a CD19-directed chimeric antigen receptor (CAR) T-cell therapy. The growing prevalence of hematologic malignancies ...

Internationally, the US has a crucial role to play in restoring confidence in democracy, as trust in democratic values has been backsliding globally for several years in the face of apparently ...

Under the terms of GOHIBIC’s approval in the EC, InflaRx will provide annual updates to EMA on the previously announced clinical platform study planned by the Biomedical Advanced Research and ...

Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption ...