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BioWorld - Saturday, January 31, 2026
Home » Keywords » Mycapssa

Items Tagged with 'Mycapssa'

ARTICLES

FDA issues CRL: Inspection woes hold up Camurus’ acromegaly drug

Oct. 22, 2024
By Karen Carey
Camurus AB received a complete response letter (CRL) from the U.S. FDA for CAM-2029 (octreotide), its extended-release injection for acromegaly, due to “facility-related deficiencies” identified during a cGMP inspection of a third-party manufacturer. The Lund, Sweden-based company noted that the CRL did not indicate any concerns related to clinical efficacy or safety. Camurus will work with the FDA and the third-party manufacturer to address the concerns, said Fredrik Tiberg, president and CEO.
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