Approval of obinutuzumab for adults with PMN follows MAJESTY, where 37% vs 6% achieved complete remission at week 104 vs tacrolimus.
News|Articles|July 1, 2026
8 FDA Headlines You Missed in June 2026
Author(s)Victoria Johnson
Fact checked by: Abigail Brooks, MA
This FDA News Month in Review provides a round-up of regulatory decisions from June 2026.
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Welcome back to our recap of this month's news and updates from the
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HIBISCUS showed a 48.7% vs 7.2% hemoglobin response at week 24, with an FDA decision expected in 2027.
The FDA approved asundexian with antiplatelet therapy after noncardioembolic ischemic stroke or high-risk TIA, based on OCEANIC-STROKE data.
Compass Pathways completed its NDA for COMP360 based on 2 phase 3 trials and a phase 2b study with more than 1000 participants with highly chronic TRD.
Children with eosinophilic esophagitis treated with dupilumab before age 6 had about half the asthma incidence of matched untreated peers 3.5 years later.
No patients with alpha-gal syndrome needed epinephrine for a food reaction during omalizumab therapy in a 64-patient cohort presented at ACAAI 2026.
Suceena Alexander, MD, joins Brendon Neuen, MBBS, PhD, and Shikha Wadhwani, MD, MS, to discuss platform trial design in IgA nephropathy and beyond.
A post hoc, unmatched comparison presented at ACAAI 2026 found similar 14-day improvements in urticaria activity with omalizumab vs remibrutinib.
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