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As of Nov 13, 2026, BLA 761400 (Lynozyfic), held by Rengeneron Pharmaceuticals, Inc., was first approved by FDA on Jul 2, 2025, with 1 approved supplement and 1 published complete response letter.
First approved: Jul 2, 2025
Review: Priority
Supplements approved: 1
Complete response letters: 1
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 2 submissions below
Date
Submission
Status
Documents
Jul 2, 2025
Original applicationNew molecular entity · Priority review
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
