FDA novel drug approvals in Q3 2026: 22 new therapies, including enlicitide, daraxonrasib, oveporexton, and first treatments for rare diseases.
News|Articles|August 1, 2025
10 FDA Headlines You Missed in July 2025
Author(s)Abigail Brooks, MA
Fact checked by: Victoria Johnson
This FDA News Month in Review provides a round-up of regulatory decisions from July 2025.
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Welcome back to our recap of this month's news and updates from the
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Catch up on key FDA approvals, major trial updates, and critical clinician insights from the last 3 months.
The FDA set a June 18, 2027, PDUFA date for the subcutaneous GP IIb/IIIa inhibitor, based on phase 3 CeleBrate data.
Remibrutinib doubled complete Total Fric Score response vs placebo at week 12 in RemIND, becoming the first therapy approved specifically for SD.
Nephrology in Q3 2026: FDA approvals for atacicept, iptacopan, finerenone, and obinutuzumab, plus 2-year IgAN data and CKD screening.
Hematology in September 2026: ASH raises ferritin thresholds for iron deficiency, plus marstacimab in hemophilia and curative SCD care.
Nephrology in September 2026: FDA approves finerenone for CKD in T1D and obinutuzumab for nephrotic syndrome, plus ORIGIN 3 IgAN data.
Late-breaking EADV data show TNFα and OX40L localize near HS draining tunnels as Navigator Medicines advances its dual-targeting bispecific antibodies.
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