FDA New Drug Applications | Traders News Source

FDA Advisory Committee Recommends Approval of Spravato (esketamine) Nasal Spray for Adults with Treatment-Resistant Depression
Source: FDA New Drug ApplicationsPublished on 2019-02-12
Zogenix Submits New Drug Application to U.S. Food & Drug Administration for Fintepla for the Treatment of Dravet Syndrome
Source: FDA New Drug ApplicationsPublished on 2019-02-06
FDA Grants Priority Review for Daiichi Sankyo’s New Drug Application for CSF1R Inhibitor Pexidartinib for Treatment of Patients with TGCT, a Rare, Debilitating Tumor
Source: FDA New Drug ApplicationsPublished on 2019-02-05
Pain Therapeutics Announces Feedback from Recent Meeting With FDA on Remoxy
Source: FDA New Drug ApplicationsPublished on 2019-02-05
SK Life Science Announces FDA Acceptance of NDA Submission for Cenobamate, an Investigational Antiepileptic Drug
Source: FDA New Drug ApplicationsPublished on 2019-02-04
Alkermes Receives Complete Response Letter From U.S. Food and Drug Administration for ALKS 5461 New Drug Application
Source: FDA New Drug ApplicationsPublished on 2019-02-01
Sunovion Receives Complete Response Letter from FDA for Apomorphine Sublingual Film (APL-130277)
Source: FDA New Drug ApplicationsPublished on 2019-01-30
Amgen And UCB Receive Positive Vote From FDA Advisory Committee In Favor Of Approval For Evenity (romosozumab)
Source: FDA New Drug ApplicationsPublished on 2019-01-21
FDA Advisory Committee Votes on Zynquista (sotagliflozin) as Treatment for Adults with Type 1 Diabetes
Source: FDA New Drug ApplicationsPublished on 2019-01-17
New Drug Application for Insomnia Disorder Treatment Lemborexant Submitted in the United States
Source: FDA New Drug ApplicationsPublished on 2019-01-15
US FDA Accepts Regulatory Submissions for Review of Tafamidis to Treat Transthyretin Amyloid Cardiomyopathy
Source: FDA New Drug ApplicationsPublished on 2019-01-14
Nabriva Therapeutics Announces Acceptance of the New Drug Application for Intravenous Contepo to Treat Complicated Urinary Tract Infections by FDA
Source: FDA New Drug ApplicationsPublished on 2019-01-04
FDA Grants Priority Review Designation for Heron Therapeutics’ NDA for HTX-011, a Non-Opioid for Postoperative Pain Management
Source: FDA New Drug ApplicationsPublished on 2018-12-31
Kala Pharmaceuticals Announces New Drug Application for KPI-121 0.25% for Dry Eye Disease Has Been Accepted for Review by the U.S. Food and Drug Administration
Source: FDA New Drug ApplicationsPublished on 2018-12-26
Braeburn Announces Tentative FDA Approval of Brixadi (buprenorphine) Extended-Release Injection for the Treatment of Moderate to Severe Opioid Use Disorder
Source: FDA New Drug ApplicationsPublished on 2018-12-23

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