Category - New Drug Applications
Takeda Receives Complete Response Letter from the U.S. FDA for TAK-721
Aquestive Therapeutics Receives Notification from FDA that It Will Not Be Ready to Take Action by December 23, 2021 for the Company’s NDA for Libervant™ (diazepam) Buccal Film
Pfizer and BioNTech Submit Supplemental Biologics License Application for U.S. FDA Approval of Comirnaty in Adolescents 12 Through 15 Years of Age
Reata Pharmaceuticals Announces Outcome of FDA Advisory Committee Meeting of Bardoxolone for the Treatment of Patients with Chronic Kidney Disease Caused by Alport Syndrome
Aurinia Announces U.S. Food and Drug Administration Acceptance of the Filing of New Drug Application and Priority Review for Voclosporin for the Treatment of Lupus Nephritis
Orphazyme Completes Rolling Submission of New Drug Application To U.S. FDA for Arimoclomol for Niemann-Pick Disease Type C
scPharmaceuticals Announces FDA Acceptance of Furoscix New Drug Application Resubmission
Mallinckrodt Announces U.S. Food and Drug Administration (FDA) Advisory Committee Voted to Recommend Terlipressin for Approval to Treat Patients with Hepatorenal Syndrome Type 1 (HRS-1)