Recent regulatory setbacks have impacted several biotech therapies. The FDA extended the review for GSK’s multiple myeloma drug Blenrep as the company prepares a relaunch after its previous withdrawal. Replimune’s oncolytic virus therapy RP1 faced a complete response letter after FDA cited trial design flaws and heterogeneity of enrolled patients, causing a 75% stock drop. Sarepta Therapeutics voluntarily paused shipments of its Duchenne muscular dystrophy gene therapy Elevidys in the U.S. amid safety concerns and regulatory challenges. These developments highlight increased scrutiny and evolving standards in gene and oncology therapy approvals.