FDA's August Approval Wave: A Monthly Narcolepsy Pill Rival, an mRNA Flu Shot and a Melanoma Virus Therapy

The Food and Drug Administration opened August with a cluster of consequential approvals, clearing three novel therapies in the space of two days, according to Drugs.com's new-approvals tracker.

Orzeyful (oveporexton), approved August 5, is an orexin receptor 2 agonist for narcolepsy type 1 — a mechanism that targets the underlying orexin deficiency of the disease rather than managing symptoms with stimulants, a shift specialists have anticipated for years.

The same day, the agency approved mFLUSIVA, an mRNA-based influenza vaccine. The clearance is a milestone for the mRNA platform's expansion beyond COVID-19, and arrives as an expert advisory panel voted unanimously in favor of a separate mRNA seasonal flu candidate for adults 50 and older, with a decision expected later this month.

On August 6, Tudriqev (vusolimogene oderparepvec) received accelerated approval for advanced cutaneous melanoma — a genetically modified oncolytic viral therapy that infects and destroys tumor cells while priming an immune response.

What's still in the queue

August's docket isn't finished: the FDA is also reviewing 177Lu-edotreotide, a radiolabeled peptide delivering targeted beta radiation for gastroenteropancreatic neuroendocrine tumors. Accelerated approvals like Tudriqev's remain conditional on confirmatory trials — a reminder that clearance is the start of the evidence story, not the end.