USFDA approves Phase 3 Acute Respiratory Distress Syndrome (ARDS), trial
The Phase 3 trial will be conducted under the auspices of the first Regenerative Medicine Advanced Therapy (RMAT) designation approved by the USFDA for an EV therapeutic
The Phase 3 trial will be conducted under the auspices of the first Regenerative Medicine Advanced Therapy (RMAT) designation approved by the USFDA for an EV therapeutic
An RMAT confers eligibility for accelerated approval and priority review of biologics licensing applications (BLA)
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