FDA New Drug Applications

February 23, 2016

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FDA Biotech News, New Drug Applications, Biotech and Pharmaceutical NDA Filings

FDA Issues Complete Response Letter for Sutimlimab, an Investigational Treatment for Hemolysis in Adults with Cold Agglutinin Disease
Source: FDA New Drug Applications Published on 2020-11-13
Heron Therapeutics Resubmits New Drug Application to FDA for HTX-011 for the Treatment of Postoperative Pain
Source: FDA New Drug Applications Published on 2020-11-13
FDA Accepts BioMarin's New Drug Application for Vosoritide to Treat Children with Achondroplasia
Source: FDA New Drug Applications Published on 2020-11-02
Zosano Pharma Receives Complete Response Letter from FDA for Qtrypta
Source: FDA New Drug Applications Published on 2020-10-21
Scynexis Announces Submission of New Drug Application to the U.S. Food and Drug Administration for Oral Ibrexafungerp for the Treatment of Vaginal Yeast Infection
Source: FDA New Drug Applications Published on 2020-10-14
CTI BioPharma Initiates Rolling Submission of New Drug Application (NDA) for Pacritinib in Myelofibrosis Patients with Severe Thrombocytopenia
Source: FDA New Drug Applications Published on 2020-10-13
FDA Advisory Committee Votes in Support of ALKS 3831 for the Treatment of Schizophrenia and Bipolar I Disorder
Source: FDA New Drug Applications Published on 2020-10-09
Kadmon Announces Submission of New Drug Application to the U.S. FDA for Belumosudil in Patients with Chronic Graft-Versus-Host Disease
Source: FDA New Drug Applications Published on 2020-09-30
BridgeBio Pharma And Affiliate Origin Biosciences Announces FDA Acceptance Of Its New Drug Application For Fosdenopterin For The Treatment Of MoCD Type A
Source: FDA New Drug Applications Published on 2020-09-29
Aquestive Therapeutics Receives Complete Response Letter from FDA for Libervant (diazepam) Buccal Film for Management of Seizure Clusters
Source: FDA New Drug Applications Published on 2020-09-25
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
U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb and bluebird bio Application for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121)
Source: FDA New Drug Applications Published on 2020-09-22
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

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