January 18, 2021

The Niche

Trusted stem cell blog & resources

FDA draft guidances stem cells

2 min read

The FDA caused major controversy by approving the drug Exondys 51 from Sarepta Therapeutics for treating Duchenne muscular dystrophy over the recommendations of a scientific panel it convened that had voted 7-3 against approval. Is this contentious Sarepta approval serve as a sign of how the FDA will deal with stem cells moving forward? Will the FDA approval, which was based on very limited, unclear data and in large part due to pressure from some patient advocates, serve as a warning to those of us hoping the agency …Read More

2 min read

Keep your hands off of my cells! At least, that is what many are telling the FDA regarding stem cells. The FDA issued four draft guidances related to stem cells in the past year or so, held two public stem cell meetings, and now must decide what it is going to do with an out of control direct-to-consumer stem cell clinic industry. In part it will need to sort through all public comments from the meeting and those submitted online. There are 4,251 comments …Read More