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News about "FDA submission"
Eisai completes FDA submission for weekly subcutaneous LEQEMBI autoinjector
Eisai has completed the rolling submission of its Supplemental Biologics License Application (sBLA) to the US Food and Drug Administration for LEQEMBI IQLIK, a once-weekly subcutaneous autoinjector formulation of lecanemab-irmb (LEQEMBI), following the FDA’s Fast Track designation.
FDA Submission | 27/11/2025 | By Darshana
Fabhalta from Novartis Meets Phase-III Goal in Slowing Kidney Decline in IgAN Patients
Fabhalta (iptacopan) from Novartis met its Phase III primary endpoint, slowing kidney function decline in IgA nephropathy (IgAN) patients. The first approved complement inhibitor for IgAN, Fabhalta builds on its 2024 U.S. accelerated approval, with data supporting a 2026 traditional FDA submission.
FDA Submission | 17/10/2025 | By Dineshwori | 111
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