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New Drug Application
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NDA
Clearside Biomedical Provides New Drug Application Update for XIPEREᵀᴹ (triamcinolone acetonide suprachoroidal injectable suspension)
PR-M08-19-NI-077
New Drug Application
Janssen Submits Supplemental New Drug Application to U.S. FDA for INVOKANA® (canagliflozin) for the Treatment of Chronic Kidney Disease in Patients with Type 2 Diabetes
PR-M04-19-NI-008
Macular Degeneration
More Positive Results for Novartis Eye Drug Brolucizumab
PAO-M11-18-NI-002
New Drug Application
Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Erdafitinib for the Treatment of Metastatic Urothelial Cancer
PR-M09-18-NI-083
NDA
Ortho Dermatologics Resubmits U.S. New Drug Application For DUOBRII™ (halobetasol propionate and tazarotene) Lotion
PR-M09-18-NI-057
Drug Application
Nektar Therapeutics Announces New Drug Application for NKTR-181 Accepted for Review by FDA
PR-M08-18-NI-011
Drug Application
FDA Accepts Larotrectinib New Drug Application and Grants Priority Review
PR-M05-18-NI-115