News Related to Rare or Fatal Diseases

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FDA Drops Two-Study Requirement for New Drug Approvals

Feb 19, 2026

The FDA will now require only one adequate and well-controlled clinical trial, combined with confirmatory evidence, to approve new drugs, ending its longtime two-study standard dating back to the 1960s.

FDA Reverses Moderna Flu Vaccine Decision, Drops Two-Study Drug Approval Requirement

Feb 18, 2026

The FDA agreed to review Moderna's mRNA flu vaccine after initially refusing the application, while separately announcing it will drop its longtime requirement for two clinical studies to approve new drugs.