U.S. President Biden signed a bill last Thursday postponing the sunset date of the rare pediatric disease Priority Review Voucher (PRV) program from September 30, 2024, to December 20, 2024. The bill, the “Continuing...more
Gene editing (GE) therapies hold immense promise for treating a myriad of diseases. Like most novel products, their development and regulatory approval necessitate careful consideration of critical factors. FDA officials...more