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Camurus AB

PharmaDeviceNews Camurus AB
Camurus has secured a December 18, 2026 FDA decision date for CAM2029 in acromegaly, but manufacturing compliance remains the decisive hurdle to US approval. Representative image.
Pharma & Biotech

CAM2029 is back before the FDA, but has Camurus finally cleared its manufacturing hurdle?

Camurus has restored a formal United States review timeline for CAM2029, but the December decision remains tied to third-party manufacturing compliance rather than new questions about clinical efficacy.

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Representative image of acromegaly drug development as Camurus’ Oclaiz FDA setback puts rare disease manufacturing risk, long-acting injectable therapies, and U.S. regulatory scrutiny under sharper focus.
Pharma & Biotech

Camurus Oclaiz CRL shows how one manufacturing site can stall a differentiated endocrine therapy

Find out how Camurus’ fresh FDA setback for Oclaiz could delay its U.S. acromegaly launch and reshape rare disease manufacturing risk.

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Representative image of injectable drug delivery devices, illustrating the growing role of long‑acting subcutaneous formulations as Camurus AB advances Oclaiz toward potential FDA approval for acromegaly.
Pharma & Biotech

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

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