Category - New Drug Applications
Nabriva Therapeutics Receives Complete Response Letter from FDA on NDA for Contepo (fosfomycin) for injection
Almirall Announces FDA Acceptance for Filing of U.S. New Drug Application (NDA) for Tirbanibulin in Actinic Keratosis
Kala Pharmaceuticals Announces FDA Acceptance of New Drug Application for Eysuvis for Dry Eye Disease
Orphazyme Initiates Rolling Submission of New Drug Application for Arimoclomol with US FDA in Niemann-Pick Disease Type C
Zealand Pharma Announces FDA acceptance of New Drug Application for the Dasiglucagon HypoPal® Rescue Pen for Treatment of Severe Hypoglycemia
FDA Grants Priority Review of Sutimlimab, Potential First Approved Treatment of Hemolysis in Adult Patients with Cold Agglutinin Disease
Eiger BioPharmaceuticals Announces FDA Acceptance of NDA for Filing with Priority Review of Zokinvy (lonafarnib) for Treatment of Progeria and Progeroid Laminopathies
Adamis Pharmaceuticals Resubmits Zimhi New Drug Application to FDA