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- FDA holds Type A meeting with Atara after CRL issued for tabelecleucel in EBV-positive PTLDThe FDA and Atara Biotherapeutics met in a Type A meeting to discuss the complete response letter (CRL) that the agency issued for the biologics license application of tabelecleucel, a therapy for…
- Sanofi asks FDA to withdraw teplizumab from fast-track review after internal disagreementSanofi has formally requested that the U.S. Food and Drug Administration remove its type 1 diabetes therapy, teplizumab, from the agency's new speedy review program. The request follows a disagree…