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FDA Calendar
Event DateSymbolDrug NameEvent Name
05/07/17TXMDYuvvexy (NDA)FDA decision on Yuvvexy for the treatment of moderate-to-severe vaginal pain during sexual intercourse
05/01/17NVSLEE011 (NDA)FDA decision on LEE011 for first-line treatment of HR+/HER2- advanced breast cancer
04/30/17RHHBYTECENTRIQ (sBLA)FDA decision on TECENTRIQ for locally advanced or metastatic urothelial carcinoma patients who are ineligible for cisplatin chemotherapy
04/29/17ARIABrigatinib (NDA)FDA decision on Brigatinib for metastatic ALK-positive non-small cell lung cancer
04/27/17BMRNBrineura (BLA)FDA decision on Brineura to treat children with CLN2 disease, a form of Batten disease
04/19/17LLYBaricitinib (NDA)FDA decision on Baricitinib for the treatment of rheumatoid arthritis
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FDA Device Approval
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