The FDA has approved six new treatments across oncology, neurology and cardiometabolic care in recent weeks, with one rare disease decision window still ahead.
Here are six approvals to know:
- The FDA approved Bristol Myers Squibb’s Zenbexus (iberdomide) Aug. 13 for use with daratumumab, hyaluronidase-fihj and dexamethasone in adults with multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and immunomodulatory agent. Zenbexus is the first FDA-approved cereblon E3 ligase modulator, a new drug class. In the phase 3 trial supporting approval, 41% of patients on the Zenbexus combination had no detectable cancer remaining after a median 16 months of follow-up, compared with 21% on a standard daratumumab-bortezomib-dexamethasone regimen.
- The FDA approved Replimune’s Tudriqev (vusolimogene oderparepvec-wtpg) Aug. 6 in combination with nivolumab for unresectable advanced cutaneous melanoma, following two prior rejections. The FDA had issued complete response letters in July 2025 and April 2026 before allowing Replimune to resubmit in May. An FDA advisory committee then voted 10-3 in July that the drug’s efficacy data were evaluable and clinically meaningful.
- The FDA approved Moderna’s mFLUSIVA Aug. 5, the first mRNA-based flu vaccine in the U.S., for adults 50 and older. The approval followed the FDA’s initial refusal to review the application, a reversal in February and a unanimous advisory committee recommendation in June, where FDA staff said the vaccine was about 27% more effective than a standard flu shot in a late-stage trial.
- The FDA approved Takeda’s Orzeyful (oveporexton) Aug. 5 for narcolepsy type 1 in adults, marking the first therapy approved to treat the full range of symptoms associated with the disorder rather than individual symptoms. The oral medication restores orexin signaling by activating the same brain receptor as the chemical messenger lost in people with the condition.
- The FDA approved GSK’s Jideytro (zidesamtinib) July 22 for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer who previously received a ROS1 kinase inhibitor.
- The FDA approved Lipfendra (enlicitide) July 16, the first oral PCSK9 inhibitor, which cut LDL cholesterol by more than half in adults with hypercholesterolemia on maximally tolerated statin therapy. Across two placebo-controlled trials of 3,207 adults, Lipfendra reduced LDL by 56% in patients with atherosclerotic cardiovascular disease or high risk for it, and by 59% in patients with heterozygous familial hypercholesterolemia.
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