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FDA, EMA, TGA and global regulatory developments

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UPDATED
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves Ohm Laboratories’ Generic Valsartan (ANDA 077492)
The FDA has granted approval for Ohm Laboratories’ generic Valsartan tablets (40‑320 mg) under application ANDA 077492.
UPDATED
Regulatory Updates
Aug 30, 2026•1 min read
Daewoong Pharmaceutical Initiates Phase 1 Trials of Olmesartan‑Indapamide Triple Antihypertensive
Daewoong Pharma received MFDS approval for two Phase 1 studies of its olmesartan‑amlodipine‑indapamide combo (DWJ1622), assessing PK and safety in fasting (44) and fed (36) healthy adults.