Daiichi Sankyo and AstraZeneca’s Enhertu has become the first new first-line option in the US for HER2-positive breast cancer in more than a decade.

The FDA has awarded its latest national priority voucher to Johnson & Johnson for a combination regimen based on Tecvayli for multiple myeloma.

Lenz Therapeutics alarmed investors on Friday when it disclosed a report of a serious complication in a patient who took its commercial eye drop for

The FDA will consider more real-world data in drug and device applications, including from large datasets that don’t have identifiable patient data, Commissioner Marty Makary

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