FDA has issued or extended multiple regulatory actions touching advanced therapies, including a delay of Capricor’s deramiocel decision date to review new data tied to a refined indication. The update comes after an earlier negative advisory committee vote, with FDA seeking additional information before deciding. Separately, the FDA has also granted humanitarian device exemption approval to Oncosil Medical’s Oncosil brachytherapy device for distal cholangiocarcinoma, positioning it as the first and only Class III FDA-approved device for that indication. Together, the actions show regulators balancing uncertainty management in complex biologics while still enabling select device pathways where evidence supports targeted clinical use.