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FDA Accepts Camurus NDA Resubmission for Oclaiz in Acromegaly, Sets December 2026 PDUFA Date

Jul 17, 2026

The FDA accepted Camurus' NDA resubmission for Oclaiz in acromegaly, setting a December 2026 PDUFA date. The filing follows a June 2026 Complete Response Letter related to third-party manufacturing, with no safety or efficacy issues. Oclaiz is a once-monthly subcutaneous octreotide already approved in the EU as Oczyesa.

Acromegaly: Patient Burden, Invisible Symptoms, and Diagnostic Challenges

May 27, 2026

Acromegaly patients face persistent symptoms including fatigue, joint pain, headaches, and brain fog despite biochemical control. Treatment burden and financial barriers remain significant, particularly in sub-Saharan Africa where diagnostic tools and therapies are often inaccessible.