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Complete Response Letter

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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Pharma & Biotech

AbbVie’s fast-acting Botox rival just hit a regulatory wall, but not where investors feared

AbbVie’s TrenibotulinumtoxinE faces an FDA manufacturing CRL. Find out what this means for approval, aesthetics and neurotoxins.

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