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Biologics License Application

FDA Setback Puts uniQure’s Huntington’s Gene Therapy Filing in Doubt

The agency signaled that Phase I/II results versus external controls would not provide the primary evidence for a BLA.

FDA Opens Door to Reconsider Capricor’s Duchenne Cell Therapy Based on HOPE-3 Data

Moderna Withdraws Flu-COVID Vaccine Application After FDA Requests More Data