FDA New Drug Applications

February 23, 2016

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ADC Therapeutics Submits Biologics License Application to the U.S. Food and Drug Administration for Loncastuximab Tesirine for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
Source: FDA New Drug Applications Published on 2020-09-24
Orphazyme Announces FDA Acceptance and Priority Review of New Drug Application for Arimoclomol for Niemann-Pick Disease Type C
Source: FDA New Drug Applications Published on 2020-09-16
Apellis Announces Submission of Pegcetacoplan Marketing Applications to FDA and EMA for Patients with PNH
Source: FDA New Drug Applications Published on 2020-09-15
Mallinckrodt Receives a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Hepatorenal Syndrome Type 1 (HRS-1)
Source: FDA New Drug Applications Published on 2020-09-14
Sol-Gel Technologies Announces FDA Acceptance for Filing of New Drug Application for Epsolay (benzoyl peroxide) for the Treatment of Inflammatory Lesions of Rosacea
Source: FDA New Drug Applications Published on 2020-09-10
Mirum Pharmaceuticals Initiates Rolling Submission of a New Drug Application for Maralixibat for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome and Launches Expanded Access Program
Source: FDA New Drug Applications Published on 2020-09-01
FDA Accepts Filing of New Drug Application for Tepotinib for the Treatment of Patients with Metastatic NSCLC with METex14 Skipping Alterations
Source: FDA New Drug Applications Published on 2020-08-25
Sarepta Therapeutics Announces FDA Acceptance of Casimersen (SRP-4045) New Drug Application for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 45
Source: FDA New Drug Applications Published on 2020-08-25
Tricida Receives Complete Response Letter from the FDA for its New Drug Application for Veverimer for the Treatment of Metabolic Acidosis and Slowing of Kidney Disease Progression in Patients with Metabolic Acidosis Associated with CKD
Source: FDA New Drug Applications Published on 2020-08-24
BioMarin Submits New Drug Application to U.S. Food and Drug Administration for Vosoritide to Treat Children with Achondroplasia
Source: FDA New Drug Applications Published on 2020-08-20
G1 Therapeutics Announces Acceptance and Priority Review of NDA for Trilaciclib for Patients with Small Cell Lung Cancer
Source: FDA New Drug Applications Published on 2020-08-17
TG Therapeutics Announces FDA Acceptance of New Drug Application for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma and Follicular Lymphoma
Source: FDA New Drug Applications Published on 2020-08-13
FDA Accepts Evinacumab Biologics License Application for Priority Review as a Treatment for Patients with HoFH, an Ultra-rare Inherited Form of High Cholesterol
Source: FDA New Drug Applications Published on 2020-08-12
Fennec Pharmaceuticals Receives Complete Response Letter from the FDA for its NDA for Pedmark To Prevent Ototoxicity Associated With Cisplatin
Source: FDA New Drug Applications Published on 2020-08-11
Fennec Pharmaceuticals Receives Complete Response Letter from the FDA for its New Drug Application for Pedmark to Prevent Ototoxicity Associated With Cisplatin in Pediatric Patients with Localized, Non-Metastatic, Solid Tumors
Source: FDA New Drug Applications Published on 2020-08-11

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