Not inferred from price. This page lists 89 decision(s) whose outcome was read from a document rather than from the share-price reaction.
44 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.
This page lists 88 FDA approvals covering February 2026 to July 2026. Each one links the FDA approval notice or the company filing that announced it.
FDA drug approvals with the decision-day move and run-up history; source-linked where verified. Labels under active validation; cross-check filings.
Questions
Are these FDA approvals verified?
Each row links its decision page, which states whether the outcome was read from a primary document or inferred from the share-price reaction; the two are never mixed in one count.
Does an FDA approval mean the drug is on the market?
Not immediately. Approval authorises marketing; launch timing is the company's, and some approved drugs launch months later or carry post-approval requirements.
Do approvals ever follow a Complete Response Letter?
Yes, routinely: a CRL sets out deficiencies, the company resubmits, and the FDA sets a new action date. The CRL archive on this site lists the published letters and what happened next.