Subscribe for the newsletter
Sign in
Articles
Expert Interviews
Roundtable
Press Releases
Videos
The Road To Series
Market Research
Thought Leaders
More
Discovery
Small Molecules
Biologics
Advanced Therapies
Manufacturing
Supply Chain
Clinical Trials
Technologies
Financing
NDA
Sort By
Newest First
1 / 1
1 / 1
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-10
Mar 26, 2024
FDA Review
Avenue Therapeutics Announces New Drug Application for IV Tramadol Accepted for Review by FDA
Nice Insight
PR-M02-20-NI-018
Feb 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-005
Jul 03, 2019
Drug Approval
Emflaza Now Approved for Treatment of Young Children
Cynthia A. Challener, Ph.D.
Pharma's Almanac
PAO-M06-19-NI-011
Jun 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-080
May 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-066-4095
Jun 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-019
Apr 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-108
Feb 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-005
Feb 01, 2018
FDA
NDA Submitted for Antimalarial Drug
Nice Insight
PAO-M12-17-NI-034
Dec 26, 2017
NDA
Kite Submits Investigational New Drug Application for KITE-585
Emilie Branch
Pharma's Almanac
PAO-M08-17-NI-018
Aug 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-006
Aug 04, 2017
FDA
Lilly’s Breast Cancer Treatment Granted Priority Review
Steve Kuehn
Nice Insight
PAO-M07-17-NI-019
Jul 13, 2017
How a CMO Can Help With Investigational New Drug Applications
Stephen A. Munk, Ph.D
Ash Stevens
PAP-APR-S01-CL-002
Apr 01, 2015
