AskBio Receives FDA Regenerative Medicine Advanced Therapy Designation for Parkinson’s
AskBio, a Bayer AG subsidiary, announced that its investigational gene therapy AB-1005 for Parkinson’s disease received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA.? This designation was based on promising Phase Ib trial data, showing a favorable safety profile and positive trends in clinical outcomes.? The RMAT designation aims to expedite the development of […]
Breakthrough in Alzheimer’s Treatment: Lomecel-B™ Receives RMAT Designation from FDA
Longeveron Inc., a clinical stage regenerative medicine biotechnology company, has achieved a significant milestone in the fight against Alzheimer’s Disease. The U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lomecel-B™ for the treatment of mild Alzheimer’s Disease. This designation underscores the potential of Lomecel-B™ to provide a new […]
FDA Approves Direct Biologics to Proceed with a Landmark Phase 3 Acute Respiratory Distress Syndrome (ARDS) Trial
AUSTIN, Texas, April 26, 2022 /PRNewswire/ — Direct Biologics, a regenerative biotechnology company with a groundbreaking extracellular vesicle (EV) platform technology, announced today that the FDA has approved the company to proceed with its Phase 3 clinical trial using its investigational EV drug, ExoFlo, to treat Acute Respiratory Distress Syndrome (ARDS) due to Covid-19. Direct […]