
A valid FDA approval under this prediction market must have occurred between January 1, 2025 and December 31, 2029. The approval must be for a novel drug (new molecular entity or new biological product) where the specified protein is explicitly listed as the primary target in the FDA approval documentation. New formulations, biosimilars, and combination products of previously approved drugs do not qualify. Verification will be conducted using the official FDA drugs database (drugs@FDA) as the authoritative source. In cases where a drug has multiple mechanisms of action, the protein must be identified as the primary, not secondary, target.
@AndrewDBlevins Could PCSK9 and MEK1/2 resolve YES? FDA lists enlicitide (Lipfendra), approved July 15, 2026, and mirdametinib (Gomekli), approved February 11, 2025, as novel drugs. Their labels section 12.1 explicitly identify PCSK9 and MEK1/2 respectively.
FDA novel approvals: Novel Drug Approvals for 2026 and Novel Drug Approvals for 2025
Labels: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220848Orig1s000lbl.pdf and https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219379s000lbl.pdf
Disclosure: I bought M25 YES on each of these two answers.
Bacterial Topoisomerase type II has been approved. https://www.nature.com/articles/d41573-025-00064-4#:~:text=The%20FDA%20has%20approved%20GSK's,uUTIs%20in%20nearly%2030%20years.
