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The Curtain Has Risen on the Competition for the First Generic Drug, so What Other Innovative Drugs in the Rare Disease Field Can We Look Forward to? Xiaobin
January 23, 2025
The CDE website shows Qilu Pharmaceutical applied for the marketing of nusinersen generic. Once controversial for high price, it treats SMA. Now many firms are involved, and SMA treatment progresses.
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
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 ...
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....
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......
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.
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...