FDA Leaders Anticipate Imminent Drug Approval Decisions

FDA leaders are targeting a decision within weeks on several pending drug approvals, as indicated by upcoming Prescription Drug User Fee Act (PDUFA) deadlines in June 20255.

Key drugs with imminent FDA decisions include Clesrovimab for RSV prevention in infants (decision expected June 10, 2025), Moderna’s mRNA-1345 RSV vaccine for high-risk adults (June 12, 2025), UGN-102 for bladder cancer (June 13, 2025), Sebetrakstat for hereditary angioedema (June 17, 2025), and Lenacapavir for HIV (June 19, 2025)5.

FDA’s review period is typically 10 months for standard review or 6 months for priority review from application acceptance. Advisory committee meetings may be convened before the final decision25.

Recent statements from FDA leaders signal an intent to reach timely decisions on these and other high-profile drugs under review, suggesting a focus on expediting regulatory actions in the coming weeks5.

Sources:

2. https://www.vaccineadvisor.com/news/fda-drug-approval-decisions-expected-may-2025/

5. https://www.guidelinecentral.com/insights/june-2026-med-preview/