Recent developments highlight regulatory challenges facing cutting-edge therapies. The FDA has extended its review of GSK's multiple myeloma drug Blenrep, delaying its relaunch efforts. Sarepta Therapeutics has voluntarily paused shipments of its Duchenne muscular dystrophy gene therapy Elevidys amid safety concerns linked to patient deaths. Roche has followed suit by halting Elevidys shipments in several countries, citing risk-benefit deliberations. Additionally, Replimune Group received a complete response letter from the FDA rejecting its oncolytic virus therapy RP1 for advanced melanoma, citing inadequate study design and heterogenous patient populations. These regulatory decisions underscore the complexities of advancing groundbreaking therapies through stringent clinical and safety evaluations.