FDA New Drug Applications

February 23, 2016

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Y-mAbs Announces Submission of Naxitamab Biologics License Application to U.S. FDA
Source: FDA New Drug Applications Published on 2020-04-01
Janssen Submits Ponesimod New Drug Application to the U.S. FDA for Treatment of Adults with Relapsing Multiple Sclerosis
Source: FDA New Drug Applications Published on 2020-03-18
U.S. FDA Accepts Regulatory Submission for Tanezumab, a Potential First-in-Class Treatment for Patients with Chronic Pain Due to Moderate-to-Severe Osteoarthritis
Source: FDA New Drug Applications Published on 2020-03-02
Zogenix Announces FDA Extension of Review Period for Fintepla in Dravet Syndrome
Source: FDA New Drug Applications Published on 2020-02-27
FDA Accepts Genentech’s Biologics License Application for Fixed-Dose Subcutaneous Combination of Perjeta And Herceptin For HER2-Positive Breast Cancer
Source: FDA New Drug Applications Published on 2020-02-24
Heron Therapeutics Announces FDA Extension of Review Period for NDA for HTX-011 for the Management of Postoperative Pain
Source: FDA New Drug Applications Published on 2020-02-19
Eton Pharmaceuticals Provides Update on ET-105 Program
Source: FDA New Drug Applications Published on 2020-02-19
FDA Accepts BioCryst’s NDA for Oral, Once Daily Berotralstat (BCX7353) to Prevent HAE Attacks
Source: FDA New Drug Applications Published on 2020-02-18
PharmaMar and Jazz Pharmaceuticals Announce FDA Acceptance and Priority Review of New Drug Application for Lurbinectedin in Relapsed Small Cell Lung Cancer
Source: FDA New Drug Applications Published on 2020-02-17
U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol-Myers Squibb’s Biologics License Application (BLA) for Lisocabtagene Maraleucel (liso-cel) for Adult Patients with Relapsed or Refractory Large B-Cell Lymphoma
Source: FDA New Drug Applications Published on 2020-02-13
Seattle Genetics Announces FDA Filing Acceptance for Priority Review of Tucatinib New Drug Application (NDA) for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer
Source: FDA New Drug Applications Published on 2020-02-13
Deciphera Pharmaceuticals Announces U.S. Food And Drug Administration Acceptance Of New Drug Application And Priority Review For Ripretinib In Patients With Advanced Gastrointestinal Stromal Tumors
Source: FDA New Drug Applications Published on 2020-02-12
Trevena Resubmits New Drug Application for Oliceridine
Source: FDA New Drug Applications Published on 2020-02-10
NDA Accepted for Filing by the FDA for Antisense Oligonucleotide Viltolarsen (NS-065/NCNP-01)
Source: FDA New Drug Applications Published on 2020-02-07
Lilly Receives FDA Priority Review for the Selpercatinib New Drug Application
Source: FDA New Drug Applications Published on 2020-01-29

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