Category - New Drug Applications
BeiGene Announces U.S. FDA Acceptance and Grant of Priority Review for its New Drug Application of Zanubrutinib in Patients with Relapsed/Refractory Mantle Cell Lymphoma
GBT Announces U.S. Food and Drug Administration Acceptance of New Drug Application and Priority Review for Voxelotor for the Treatment of Sickle Cell Disease
Tricida Announces Submission of New Drug Application for Veverimer for the Treatment of Metabolic Acidosis in Patients with Chronic Kidney Disease
United Therapeutics Announces FDA Acceptance of Trevyent New Drug Application For Review
Intra-Cellular Therapies Provides Lumateperone Regulatory Update
FDA Allergenic Products Advisory Committee Votes to Support the Use of Aimmune’s Palforzia (AR101) for Peanut Allergy
Vertical Pharmaceuticals, LLC, an Osmotica Company, Announces Submission of New Drug Application for RVL-1201
Kala Pharmaceuticals Receives FDA Complete Response Letter for KPI-121 0.25% NDA and Plans to Respond with Data From STRIDE 3 Trial