Category - New Drug Applications
Reata Pharmaceuticals Receives Complete Response Letter From The FDA for Bardoxolone for the Treatment of Patients with Chronic Kidney Disease Caused by Alport Syndrome
Phathom Pharmaceuticals Submits Vonoprazan NDA to FDA for the Treatment of Erosive Esophagitis
Nymox Announces Submission of New Drug Application (NDA) to the FDA for Fexapotide Triflutate
Gilead Receives Complete Response Letter From U.S. FDA for Investigational Lenacapavir Due to Vial Compatibility Issues
U.S. Food and Drug Administration (FDA) Accepts Mirati Therapeutics’ New Drug Application for Adagrasib as Treatment of Previously Treated KRASG12C-Mutated Non-Small Cell Lung Cancer
Orphazyme Provides Update for Planned NDA Resubmission for Arimoclomol for the Treatment of Niemann-Pick Disease Type C in the United States
Spectrum Pharmaceuticals Announces Acceptance of New Drug Application Filing for Poziotinib
Cytokinetics Announces FDA Acceptance of New Drug Application for Omecamtiv Mecarbil for the Treatment of Heart Failure With Reduced Ejection Fraction