On May 3, 2024, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the IRA. Notwithstanding the...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