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Building a Regulatory Roadmap for IND, NDA, and BLA
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
Avenue Therapeutics Announces New Drug Application for IV Tramadol Accepted for Review by FDA
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
Sobi
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
Emflaza Now Approved for Treatment of Young Children
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
Amarin
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
Glenmark Pharmaceuticals
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
Dr. Reddy's Laboratories
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
Allergan, plc
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
Theravance Biopharma
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
NDA Submitted for Antimalarial Drug
FDA

NDA Submitted for Antimalarial Drug

Nice Insight

PAO-M12-17-NI-034Dec 26, 2017
Kite Submits Investigational New Drug Application for KITE-585
NDA

Kite Submits Investigational New Drug Application for KITE-585

Emilie Branch

Pharma's Almanac

PAO-M08-17-NI-018Aug 11, 2017
New Drug Approved to Prevent Hereditary Angioedema Attacks Now Available in the US
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
Lilly’s Breast Cancer Treatment Granted Priority Review
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

How a CMO Can Help With Investigational New Drug Applications

Stephen A. Munk, Ph.D

Ash Stevens

PAP-APR-S01-CL-002Apr 01, 2015
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