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FDA Calendar
Event DateSymbolDrug NameEvent Name
08/23/17NVSZykadia (sNDA)FDA decision on Zykadia as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive
08/14/17AMGNBLINCYTO (sBLA)FDA decision on expanded indication of BLINCYTO to treat Ph+ relapsed or refractory B-cell precursor ALL
08/10/17DVAXHEPLISAV-B (NDA resubmission)FDA decision on HEPLISAV-B for treatment of hepatitis B
08/02/17BMYOpdivo (sBLA)FDA decision on Opdivo to treat previously treated mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer patients
07/28/17DVAXHEPLISAV-B (NDA)FDA panel to review HEPLISAV-B against hepatitis B
07/21/17PBYIPB272 (Neratinib) (NDA)FDA decision on PB272 for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer
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FDA Device Approval
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