Category - New Drug Applications
Ocular Therapeutix Announces NDA Resubmission of Dextenza
Karyopharm Initiates Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Selinexor as a Treatment for Patients with Penta-Refractory Multiple Myeloma
FDA Advisory Committee Endorses the Effectiveness and Safety of Single-Dose Tafenoquine for the Radical Cure of P. vivax Malaria
Alexion Submits Application for Priority Review and Approval of ALXN1210 as a Treatment for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) in the U.S.
Amgen And UCB Resubmit Biologics License Application (BLA) For Evenity (romosozumab) To The US FDA
Pain Therapeutics Announces Results of FDA Advisory Committee Meeting for Remoxy ER
FDA Grants Priority Review for Pfizer’s New Drug Application for Glasdegib in Patients with Previously Untreated Acute Myeloid Leukemia
FDA Issues Complete Response Letter for Duobrii (halobetasol propionate and tazarotene) Lotion