Can Amylyx turn open-label AMX0035 signals into a credible Phase 3 Wolfram syndrome trial?
Amylyx has rare disease momentum, but open-label data are not destiny. AMX0035 now faces its real Wolfram syndrome test.
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 […]
Corcept’s relacorilant CRL leaves endocrinology ambitions in limbo as oncology pivot takes center stage
Find out why FDA’s complete response letter for Corcept’s relacorilant could reshape treatment of hypercortisolism, with implications for oncology approval.