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Regulatory Affairs

European Medicines Agency EU Clinical Trials Register European Union FDA Approval Biologics License Application EMA Guidelines FDA Approval Process FDA Response Letters AI in Healthcare FDA and EMA Approval

FDA Issues Second Rejection of Atara’s EBV+ PTLD Therapy Tabelecleucel

Regulators question efficacy evidence from the single-arm ALLELE study.

MHRA Reforms and AI Cut UK Clinical Trial Approval Times to 41 Days

Arecor and Sequel to Co-Develop AT278 With Twiist AID for High-Dose Diabetes Care