Pharmaceutical Executive Daily: FDA's Approval of Lerochol

Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences industry.

In today’s Pharmaceutical Executive Daily, the FDA approves a new LDL-lowering therapy, Sanofi announces two strategic deals spanning Alzheimer’s disease and B-cell depletion, and the agency issues a national priority voucher tied to Tecvayli in multiple myeloma.

The FDA has approved Lerochol for adults with elevated LDL cholesterol, expanding treatment options for patients who require additional lipid lowering beyond existing therapies. The approval reflects continued regulatory momentum around cardiovascular risk reduction and differentiated mechanisms in dyslipidemia.

Sanofi is expanding its pipeline through two separate agreements, reaching a deal with Adel for a novel Alzheimer’s disease therapy while also partnering with Dren Bio on a B-cell depletion program. The moves highlight Sanofi’s dual focus on neurodegenerative disease innovation and next-generation immunology approaches.

In regulatory news, the FDA has awarded a national priority voucher associated with Tecvayli for relapsed or refractory multiple myeloma. The designation reinforces the agency’s use of vouchers to accelerate development timelines for therapies addressing significant unmet medical needs in oncology.

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