FDA New Drug Applications

February 23, 2016

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Correvio Resubmits Brinavess (vernakalant) New Drug Application to U.S. FDA for the Treatment of Patients with Recent Onset Atrial Fibrillation
Source: FDA New Drug Applications Published on 2019-06-24 By bwadmin
Daiichi Sankyo Provides Update on FDA Review of Quizartinib for the Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
Source: FDA New Drug Applications Published on 2019-06-21 By bwadmin
Blueprint Medicines Submits New Drug Application to U.S. Food and Drug Administration for Avapritinib for the Treatment of PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST
Source: FDA New Drug Applications Published on 2019-06-14 By bwadmin
Xeris Pharmaceuticals Receives Notification of PDUFA Date Extension for Gvoke
Source: FDA New Drug Applications Published on 2019-06-06 By bwadmin
US FDA and EMA Accept Applications for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis
Source: FDA New Drug Applications Published on 2019-06-06 By bwadmin
Celgene Corporation and Acceleron Pharma Announce U.S. FDA Accepts Luspatercept Biologics License Application in Myelodysplastic Syndromes and Beta-Thalassemia
Source: FDA New Drug Applications Published on 2019-06-04 By bwadmin
Epizyme Submits New Drug Application to the U.S. FDA for Tazemetostat for the Treatment of Patients with Epithelioid Sarcoma
Source: FDA New Drug Applications Published on 2019-05-30 By bwadmin
Agile Therapeutics Resubmits New Drug Application (NDA) for its Transdermal Low-Dose Contraceptive Patch, Twirla
Source: FDA New Drug Applications Published on 2019-05-17 By bwadmin
Lipocine Announces Tlando NDA PDUFA Action Date of November 9, 2019
Source: FDA New Drug Applications Published on 2019-05-14 By bwadmin
RedHill Biopharma Submits New Drug Application for Talicia for H. pylori Infection
Source: FDA New Drug Applications Published on 2019-05-07 By bwadmin
Zynerba Pharmaceuticals Receives Fast Track Designation for Zygel for the Treatment of Behavioral Symptoms Associated with Fragile X Syndrome (FXS)
Source: FDA New Drug Applications Published on 2019-05-06 By bwadmin
Esperion Announces U.S. FDA Acceptance of New Drug Applications (NDAs) for Both Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet for Filing and Regulatory Review
Source: FDA New Drug Applications Published on 2019-05-05 By bwadmin
Complete Response Letter from FDA for Barhemsys
Source: FDA New Drug Applications Published on 2019-05-03 By bwadmin
Heron Therapeutics Receives Complete Response Letter For HTX-011 For The Management Of Postoperative Pain
Source: FDA New Drug Applications Published on 2019-05-01 By bwadmin
Nabriva Therapeutics Receives Complete Response Letter from FDA on NDA for Intravenous Contepo (fosfomycin) for injection
Source: FDA New Drug Applications Published on 2019-04-30 By bwadmin

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