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Results For "Direct-Biologics"

2 News Found

USFDA approves Phase 3 Acute Respiratory Distress Syndrome (ARDS), trial
Biotech | April 22, 2022

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


USFDA grants direct RMAT designation for the use of ExoFlo in Covid-19 related ARDS
Biotech | April 13, 2022

USFDA grants direct RMAT designation for the use of ExoFlo in Covid-19 related ARDS

An RMAT confers eligibility for accelerated approval and priority review of biologics licensing applications (BLA)