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Biologics License Application

MOLBREEVI Clinical Trials Manufacturing Issues Accelerated Approval Pathway Statistical Analysis Plans

Securities Suit Targets Capricor Over FDA Findings on Trial Analysis

Regulators have extended their review after finding Capricor’s post‑study changes to its statistical plan made some analyses effectively post‑hoc.

Class Action Filed Against Atara Biotherapeutics Over Alleged Misstatements on FDA Setbacks

Investor Class Actions Target Atara Over FDA Setbacks to EBVALLO