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IND, NDA, and BLA
Building a Regulatory Roadmap for IND, NDA, and BLA
PAO-03-24-CL-10
FDA Review
Avenue Therapeutics Announces New Drug Application for IV Tramadol Accepted for Review by FDA
PR-M02-20-NI-018
FDA Approval
Dova Pharmaceuticals Announces FDA Approval of Supplemental New Drug Application for DOPTELET® (avatrombopag) for Treatment of Chronic Immune Thrombocytopenia (ITP)
PR-M07-19-NI-005
NDA
Zosano Pharma Completes Site Qualification Batches at Contract Manufacturing Organization as it Prepares for NDA Submission of Qtrypta™
PR-M07-19-NI-008
Drug Approval
Emflaza Now Approved for Treatment of Young Children
PAO-M06-19-NI-011
NDA
U.S. FDA Grants Priority Review For Vascepa® (Icosapent Ethyl) Supplemental New Drug Application Seeking Cardiovascular Risk Reduction Indication
PR-M05-19-NI-080
FDA
BioArctic: U.S. Food and Drug Administration Approves Investigational New Drug Applicationfor ABBV-0805
PR-M02-19-NI-025
FDA Approval
The US FDA Approves First Supplemental Abbreviated New Drug Application (sANDA) for Glenmark Pharmaceuticals' Manufacturing Facility in Monroe, North Carolina
PR-M06-18-NI-066
NDA
Dr. Reddy's Laboratories and its U.S. subsidiary Promius Pharma announce the filing of an NDA for its migraine candidate
PR-M04-18-NI-019
NDA
FDA Acceptance of Medicines360's Filing for supplemental New Drug Application for LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg
PR-M02-18-NI-108
New Drug Application
Theravance Biopharma and Mylan Announce FDA Acceptance of New Drug Application for Revefenacin (TD-4208) in Adults with Chronic Obstructive Pulmonary Disease
PR-M02-18-NI-005
FDA
NDA Submitted for Antimalarial Drug
PAO-M12-17-NI-034
NDA
Kite Submits Investigational New Drug Application for KITE-585
PAO-M08-17-NI-018
NDA
New Drug Approved to Prevent Hereditary Angioedema Attacks Now Available in the US
PAO-M08-17-NI-006
FDA
Lilly’s Breast Cancer Treatment Granted Priority Review
PAO-M07-17-NI-019
How a CMO Can Help With Investigational New Drug Applications
PAP-APR-S01-CL-002