regulatory

News

FDA starts a review of Roche's Gazyva as a treatment for lupus nephritis, an indication that analysts think could unlock renewed sales growth.

News

Lawrence Tallon has been named head of the MHRA, effective 1st April, replacing Dame June Raine who is retiring.

News

Eisai and Biogen have been unable to persuade Australia's medicines regulator to approve their Alzheimer's therapy Leqembi with a narrower label.

News

Regeneron has refiled its CD20xCD3 bispecific odronextamab for lymphoma with the FDA, which was rejected last year, but is seeking a narrower label.

News

The FDA is set to decide on MSD's Keytruda as perioperative treatment of locally advanced head and neck squamous cell carcinoma in June.

News

The FDA has started a priority review of Bristol Myers Squibb's Opdivo and Yervoy as first-line therapy for MSI-H/dMMR colorectal cancer.