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Dec 18, 2025 12:10 PM

Merck Cholesterol, Cancer Drugs May Enter FDA Fast-Track Program: Report

The U.S. Food and Drug Administration (FDA) is preparing to fast-track reviews of two experimental Merck & Co. Inc. (NYSE:MRK) drugs with potential blockbuster sales.

Merck's cholesterol treatment enlicitide decanoate and cancer therapy sacituzumab tirumotecan (sac-TMT) have been reportedly selected for the FDA Commissioner's National Priority Voucher (CNPV) program, which accelerates regulatory decisions for medicines deemed critical to public health or national interests.

If finalized, the drugs would become the 17th and 18th to enter the program, according to internal documents reviewed by Reuters.

Also Read: Pallone, Sanders Warn FDA’s Fast-Track Vouchers Could Create Political Favoritism, Safety Risks

In September, Merck ...