FDA New Drug Applications

February 23, 2016

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Biogen Completes Submission of Biologics License Application to FDA for Aducanumab as a Treatment for Alzheimer’s Disease
Source: FDA New Drug Applications Published on 2020-07-08
Blueprint Medicines Announces Submission of New Drug Application to FDA for Pralsetinib for the Treatment of Advanced RET Mutant and RET Fusion-Positive Thyroid Cancers
Source: FDA New Drug Applications Published on 2020-07-01
scPharmaceuticals Announces Furoscix NDA Resubmission
Source: FDA New Drug Applications Published on 2020-07-01
Mezzion Announces Submission of New Drug Application for its Orphan Drug Udenafil to Treat Patients who have undergone the Fontan Operation for Single Ventricle Heart Disease
Source: FDA New Drug Applications Published on 2020-06-30
Verrica Pharmaceuticals Provides Regulatory Update on VP-102
Source: FDA New Drug Applications Published on 2020-06-29
Heron Therapeutics Receives Complete Response Letter for HTX-011 for the Management of Postoperative Pain
Source: FDA New Drug Applications Published on 2020-06-29
Sarepta Therapeutics Completes Submission of New Drug Application Seeking Approval of Casimersen (SRP-4045) for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 45
Source: FDA New Drug Applications Published on 2020-06-26
Mayne Pharma Announces FDA Filing Acceptance of New Drug Application for E4/DRSP in the US
Source: FDA New Drug Applications Published on 2020-06-24
Nabriva Therapeutics Receives Complete Response Letter from FDA on NDA for Contepo (fosfomycin) for injection
Source: FDA New Drug Applications Published on 2020-06-19
Orphazyme Initiates Rolling Submission of New Drug Application for Arimoclomol with US FDA in Niemann-Pick Disease Type C
Source: FDA New Drug Applications Published on 2020-05-29
Kala Pharmaceuticals Announces FDA Acceptance of New Drug Application for Eysuvis for Dry Eye Disease
Source: FDA New Drug Applications Published on 2020-05-26
Zealand Pharma Announces FDA acceptance of New Drug Application for the Dasiglucagon HypoPal® Rescue Pen for Treatment of Severe Hypoglycemia
Source: FDA New Drug Applications Published on 2020-05-22
Adamis Pharmaceuticals Resubmits Zimhi New Drug Application to FDA
Source: FDA New Drug Applications Published on 2020-05-20
Eiger BioPharmaceuticals Announces FDA Acceptance of NDA for Filing with Priority Review of Zokinvy (lonafarnib) for Treatment of Progeria and Progeroid Laminopathies
Source: FDA New Drug Applications Published on 2020-05-19
FDA Grants Priority Review of Sutimlimab, Potential First Approved Treatment of Hemolysis in Adult Patients with Cold Agglutinin Disease
Source: FDA New Drug Applications Published on 2020-05-14

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