regulatory

News

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

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

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

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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.

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Boehringer Ingelheim's oral HER2 inhibitor zongertinib has started an FDA review as a lung cancer treatment with a decision due in the third quarter.

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Gilead's already dominant position in HIV PrEP could be extended if the FDA approves a new twice-yearly injectable product later this year.