Fate Therapeutics selected for FDA manufacturing pilot program
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Fate Therapeutics Selected for U.S. FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program to Support Manufacturing Readiness of FT819
May 5, 2026 8:30 AM EDTFDA Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program supports the acceleration of manufacturing readiness for therapies with expedited clinical development timelines
Current Regenerative Medicine Advanced Therapy (RMAT) designation and CDRP participation provide opportunity for expedited regulatory pathway and advancement of FT819 Phase 2 potentially registrational clinical trial in patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with lupus nephritis
SAN DIEGO, May 05, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent... More
