Camurus’s FDA review restart for Oclaiz puts long-acting octreotide on track for a potential U.S. launch in mid-2026
Camurus AB announced that the U.S. Food and Drug Administration (FDA) has accepted its resubmission of the New Drug Application for Oclaiz (CAM2029), an extended-release octreotide injection for acromegaly. The agency assigned a Prescription Drug User Fee Act (PDUFA) action date of June 10, 2026, reinitiating regulatory review after an earlier Complete Response Letter related […]