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CStone submits new drug application for TIBSOVO(R) for treatment of relapsed/refractory AML
biospectrumasia
June 03, 2019
First to-be-approved treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible IDH1 mutation
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New Drug Application for Insomnia Disorder Treatment Lemborexant Submitted in the United States
drugs
January 24, 2019
Eisai Co., Ltd. (CEO: Haruo Naito, “Eisai”) and Purdue Pharma L.P. (President and CEO: Craig Landau, MD, “Purdue Pharma”) today announced that ...
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Adamis Pharmaceuticals Submits New Drug Application to FDA for Its Tadalafil Sublingual Tablet
pharmafocusasia
January 02, 2019
Adamis Pharmaceuticals Corporation today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for....
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FDA Accepts New Drug Application for KPI-121 0.25%
americanpharmaceuticalreview
December 29, 2018
Kala Pharmaceuticals announced the New Drug Application (NDA) for KPI-121 0.25%, a product candidate for the temporary relief of signs and symptoms of dry eye disease utilizing......
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FDA accepts new drug application for Novartis’ Promacta
pharmaceutical-technology
June 01, 2018
The FDA’s award of a priority review is based on Novartis’ study in which 52% of treatment-naïve SAA patients achieved complete response at six months when treated with Promacta and standard IST.
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Lupin submits New Drug Application for Etanercept biosimilar in Japan
biospectrumasia
May 10, 2018
Pharma major Lupin announced that YL Biologics (YLB) – its JV with Yoshindo and Kyowa (Lupin’s Subsidiary) in Japan has submitted a New Drug Application for...