FDA cleared Moderna’s mRNA flu vaccine mFLUSIVA (mRNA-1010) for adults 50–64 and 65+, marking the first US approval of a seasonal flu shot built on mRNA. The path included a refusal-to-file earlier in the year before a swift reversal after Moderna supplied additional data, culminating in an accelerated framework for the older cohort. In parallel, FDA granted accelerated approval to Replimune’s oncolytic virus therapy RP1 (marketed as Tudriqev) for advanced melanoma in combination with Bristol Myers Squibb’s Opdivo (pembrolizumab) after the drug was rejected twice previously. The decision followed an FDA advisory committee vote and hinged on a single-arm signal, with confirmatory Phase 3 readouts expected later. Together, the approvals highlight regulators’ willingness to act on late-breaking efficacy signals in difficult patient populations—while still tying continued approval to confirmatory evidence for the oncology asset.