The twin designations are designed to speed up the development and review of promising medicines targeting serious conditions with high unmet need
The Danish biotech company confirmed the global study will begin in the second half of 2026
After Phase 3 results show major hair regrowth gains
The submission is backed by positive results from the Phase 3 AFFIRM study
The approval makes Cipla’s product the first AB-rated generic therapeutic equivalent of Ventolin HFA
The investment will bring in cutting-edge downstream fermentation technology, strengthening the company’s contract manufacturing capabilities for drug substances
A decision is expected by August 17, 2026 under the Prescription Drug User Fee Act timeline
The start of our Phase 3 trial for an H5 influenza vaccine marks a significant milestone
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