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Home » FDA Issues CRL for Pfizer and OPKO Health’s Growth Hormone Treatment
FDA Issues CRL for Pfizer and OPKO Health’s Growth Hormone Treatment
Pfizer and OPKO Health drew a Complete Response Letter (CRL) from the FDA for their Biologics License Application (BLA) for Ngenla (somatrogon), an injectable, long-acting recombinant human growth hormone for the treatment of growth hormone deficiency (GHD) in pediatric patients.