Bakslag för Camurus i USA – FDA begär mer info

Lundbaserade Camurus får bakläxa på sin FDA-ansökan för läkemedelskandidaten CAM2029 som behandling för hormonsjukdomen akromegali, eller jätteväxt.

By Anders Göransson

June 11, 2026 9:51 AM

I ett så kallat Complete Response Letter (CRL) hänvisar myndigheten till observationer som gjorts vid en inspektion av en kontraktstillverkare i september 2024.

Enligt Camurus kräver FDA ”tillfredsställande hantering av dessa observationer” innan ansökan kan godkännas. Det kan bland annat innefatta en ny inspektion av den utpekade anläggningen.

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