IND, NDA, and BLA
Building a Regulatory Roadmap for IND, NDA, and BLA
Rebecca Lamb-Wharton, Ph.D.; Brenda Schlenk, RPh; Mamadou Diallo, PharmD
PAO-03-24-CL-10Mar 26, 2024
FDA Review
Avenue Therapeutics Announces New Drug Application for IV Tramadol Accepted for Review by FDA
Nice Insight
PR-M02-20-NI-018Feb 14, 2020
FDA Approval
Dova Pharmaceuticals Announces FDA Approval of Supplemental New Drug Application for DOPTELET® (avatrombopag) for Treatment of Chronic Immune Thrombocytopenia (ITP)
Sobi
PR-M07-19-NI-005Jul 03, 2019
Drug Approval
Emflaza Now Approved for Treatment of Young Children
Cynthia A. Challener, Ph.D.
Pharma's Almanac
PAO-M06-19-NI-011Jun 20, 2019
NDA
U.S. FDA Grants Priority Review For Vascepa® (Icosapent Ethyl) Supplemental New Drug Application Seeking Cardiovascular Risk Reduction Indication
Amarin
PR-M05-19-NI-080May 29, 2019
FDA Approval
The US FDA Approves First Supplemental Abbreviated New Drug Application (sANDA) for Glenmark Pharmaceuticals' Manufacturing Facility in Monroe, North Carolina
Glenmark Pharmaceuticals
PR-M06-18-NI-066-4095Jun 19, 2018
NDA
Dr. Reddy's Laboratories and its U.S. subsidiary Promius Pharma announce the filing of an NDA for its migraine candidate
Dr. Reddy's Laboratories
PR-M04-18-NI-019Apr 05, 2018
NDA
FDA Acceptance of Medicines360's Filing for supplemental New Drug Application for LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg
Allergan, plc
PR-M02-18-NI-108Feb 28, 2018
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
Theravance Biopharma
PR-M02-18-NI-005Feb 01, 2018
FDA
NDA Submitted for Antimalarial Drug
Nice Insight
PAO-M12-17-NI-034Dec 26, 2017
NDA
Kite Submits Investigational New Drug Application for KITE-585
Emilie Branch
Pharma's Almanac
PAO-M08-17-NI-018Aug 11, 2017
NDA
New Drug Approved to Prevent Hereditary Angioedema Attacks Now Available in the US
Cynthia A. Challener, Ph.D.
Pharma's Almanac
PAO-M08-17-NI-006Aug 04, 2017
FDA
Lilly’s Breast Cancer Treatment Granted Priority Review
Steve Kuehn
Nice Insight
PAO-M07-17-NI-019Jul 13, 2017
How a CMO Can Help With Investigational New Drug Applications
Stephen A. Munk, Ph.D
Ash Stevens
PAP-APR-S01-CL-002Apr 01, 2015