FDA New Drug Applications

February 23, 2016

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Kala Pharmaceuticals Receives FDA Complete Response Letter for KPI-121 0.25% NDA and Plans to Respond with Data From STRIDE 3 Trial
Source: FDA New Drug Applications Published on 2019-08-08
Blueprint Medicines Announces FDA Acceptance of New Drug Application for Avapritinib for the Treatment of PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST
Source: FDA New Drug Applications Published on 2019-08-07
Foamix Submits New Drug Application to U.S. FDA for FMX103 for the Treatment of Moderate-to-Severe Papulopustular Rosacea
Source: FDA New Drug Applications Published on 2019-08-05
Ultragenyx Announces Submission of New Drug Application to FDA for UX007 (triheptanoin) for Treatment of Long-Chain Fatty Acid Oxidation Disorders
Source: FDA New Drug Applications Published on 2019-08-01
Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-105
Source: FDA New Drug Applications Published on 2019-08-01
Sunovion Announces Acceptance by the U.S. FDA of the New Drug Application for Dasotraline for the Treatment of Adults with Moderate-to-Severe Binge Eating Disorder
Source: FDA New Drug Applications Published on 2019-07-30
Epizyme Announces FDA Filing Acceptance of New Drug Application and Priority Review for Tazemetostat for the Treatment of Epithelioid Sarcoma
Source: FDA New Drug Applications Published on 2019-07-25
FDA Accepts Correvio's Resubmitted New Drug Application for Brinavess (vernakalant)
Source: FDA New Drug Applications Published on 2019-07-25
Intra-Cellular Therapies Provides Update on FDA Advisory Committee Meeting for Lumateperone for the Treatment of Schizophrenia
Source: FDA New Drug Applications Published on 2019-07-23
Vertex Submits New Drug Application to the U.S. FDA for Triple Combination Regimen of VX-445 (Elexacaftor), Tezacaftor and Ivacaftor in Cystic Fibrosis
Source: FDA New Drug Applications Published on 2019-07-22
FDA Accepts File and Accelerates Review of Novartis Sickle Cell Disease Medicine Crizanlizumab (SEG101)
Source: FDA New Drug Applications Published on 2019-07-16
Astellas and Seattle Genetics Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer
Source: FDA New Drug Applications Published on 2019-07-16
FDA to Review Isatuximab as a Potential Treatment for Relapsed/Refractory Multiple Myeloma
Source: FDA New Drug Applications Published on 2019-07-10
Neurocrine Biosciences Announces FDA Acceptance of New Drug Application for Opicapone as an Adjunctive Treatment for Patients with Parkinson's Disease
Source: FDA New Drug Applications Published on 2019-07-10
Acacia Pharma Plans to Resubmit the Barhemsys NDA in Q3 2019
Source: FDA New Drug Applications Published on 2019-07-08

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