F.D.A. Sharply Limits Use of Drug Linked to Two Teen Deaths

• The FDA's recent action to limit Elevidys usage stems from serious liver complications and its association with two teen fatalities, prompting a critical review of its application in younger patients. This decision highlights the ongoing scrutiny of gene therapies and their safety profiles.
• The implications for Sarepta Therapeutics are significant, as Elevidys is central to its business model, potentially affecting investor confidence and the company's market valuation of around $2 billion. The limitations may hinder future growth and innovation within the company.
• While no related articles are available, this situation reflects broader concerns in the biotech industry regarding the balance between innovative treatments and patient safety, emphasizing the need for rigorous regulatory oversight.

— via World Pulse Now AI Editorial System