Category - New Drug Applications
Intra-Cellular Therapies Completes Submission of New Drug Application for Lumateperone for Treatment of Schizophrenia
Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Erdafitinib for the Treatment of Metastatic Urothelial Cancer
Ardelyx Submits New Drug Application for Tenapanor for IBS-C
Acorda Announces FDA Extends Inbrija NDA Review Period
Janssen Submits Esketamine Nasal Spray New Drug Application to U.S. FDA for Treatment-Resistant Depression
FDA Issues a Complete Response Letter for New Drug Application for Dasotraline for the Treatment of ADHD
Akcea and Ionis Receive Complete Response Letter for Waylivra from FDA
Mallinckrodt Confirms Receipt of Stannsoporfin Complete Response Letter