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December 18 Product: Xcoverys Ensacove Indication: ALK-positive locally advanced or metastatic non-small cell lung cancer Florida-based Xcovery Holdings on Thursday scored its first FDA approval with the regulatory greenlight for Ensacove (ensartinib) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are also positive for the anaplastic lymphoma kinase (ALK) fusion gene

Before the FDA stepped in, GenoGenix was producing ineligible drugs (drugs not allowed under FDA rules for 503B outsourcing facilities), including peptide injectables such as 5-Amino-1MQ and NAD+, using ingredients not on the FDAs approved bulk drug substances list

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