France will introduce in 2026 a “fast-track” pathway aimed at accelerating the authorisation of certain mono-national clinical trials. Reserved in particular for early-phase studies, serious diseases ...
The main expected benefit is a shift towards further simplification and standardization for eligible transactions. The objective of the SRT Fast-Track process is to significantly reduce the time ...
CAMBRIDGE, Mass., Jan. 10, 2025 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of ...
FDA grants Fast Track Designation for azenosertib in Cyclin E1 positive cancer. Clinical data update to follow on January 29, 2025. Zentalis Pharmaceuticals announced that the U.S. FDA has granted ...
Treatment with nipocalimab led to reduced lupus disease activity in phase 2 trial. (HealthDay News) — Nipocalimab has been granted U.S. Food and Drug Administration Fast Track designation as a ...
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