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April 10, 2025
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With regulatory clearance for people aged ≥18 years with diabetes, Dexcom G7 boasts the longest-lasting wearable and most accurate CGM system.
April 09, 2025
Assigned a PDUFA target date of August 27, 2025, the resubmitted application for the wet AMD treatment will offer another chance for US approval.
April 08, 2025
BRIMOCHOL PF, a combination eye drop for presbyopia, achieved all primary and secondary endpoints in its most recent trial.
April 03, 2025
Regulatory approval of inebilizumab for immunoglobulin G4-related disease (IgG4-RD) marks the first and only available treatment for adults.
Aldeyra announces intention to resubmit NDA with new trial data in mid-year 2025.
The approval indicates Novartis's atrasentan (Vanrafia) for proteinuria reduction in primary IgA nephropathy.
April 02, 2025
The FDA granted fast-track status to Biogen’s BIIB080, a tau-targeting therapy for Alzheimer Disease, which is now being evaluated in the global phase 2 CELIA study.
April 01, 2025
The first quarter of 2025 saw approvals in diabetes, depression, kidney disease, and pain, among others. Read more about high-impact approvals of Q1 now.
The FDA accepted an sNDA for pegcetacoplan for C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis.
March 31, 2025
This FDA News Month in Review provides a round-up of regulatory decisions from March 2025.
