This page lists 47 Complete Response Letters covering January 2025 to June 2026. A Complete Response Letter means the FDA declined to approve the application as submitted, and it does not by itself mean the drug is rejected for good.
Not inferred from price. This page lists 47 decision(s) whose outcome was read from a document rather than from the share-price reaction.
18 of them link that document; the rest are older entries we have not yet gone back and sourced, and we would rather say so than call them all verified. A further 0 record(s) in our archive have their outcome inferred from the share-price reaction rather than read from a filing, and they are deliberately not listed under a heading that asserts what the FDA did. They remain in the
full archive, labelled unverified. We published one such inference that turned out to be impossible; see
corrections.
FDA Complete Response Letters with the reason, decision-day move and run-up. Labels under active validation; cross-check filings.