Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Desmoid tumors are non-cancerous, but locally aggressive and invasive soft-tissue tumors that can lead to substantial morbidity and can be life threatening. . Ogsiveo is 50mg oral tablet. Nirogacestat is not yet approved for any indication in any other jurisdiction by any other health authority. SpringWorks expects to file Ogsiveo in Europe (EMA) in 2024
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