The FDA’s accelerated approval of GENGLYCOS™ (pariglasgene brecaparvovec-opnr), also known as DTX401, introduces the first FDA-approved treatment option for glycogen storage disease type Ia (GSDIa).

Hospital contracting is a critical element for health plans because it dictates the plan's financial viability, price predictability, and market competitiveness.

In the next six months, the FDA expects to issue decisions on three novel therapies.

On April 23, 2026, the US Food and Drug Administration approved gene therapy Otarmeni (lunsotogene parvec-cwha) for the treatment of genetic hearing loss.