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Clinical - BLA/NDA/ANDA
Pacira (PCRX) Announces Completion Of End-of-Review Process With FDA Regarding EXPAREL sNDA For Nerve Block 5/28/2015 10:39:39 AM
IGI Laboratories, Inc. Announces Third ANDA Submission Of 2015 5/28/2015 6:31:07 AM
FDA Seeks More Info Before Approving AMAG Pharmaceuticals, Inc. (AMAG)'s Single-Dose Vial of Makena 5/28/2015 6:25:01 AM
Your Analyst-Vetted Guide to the Five Blockbuster Drugs the FDA May Approve This Summer 5/26/2015 9:57:23 AM
FDA Accepts BPL’s Amended BLA Submission For Coagadex (Coagulation Factor X, Human) 5/27/2015 10:24:45 AM
ZS Pharma (ZSPH) Submits New Drug Application To FDA For ZS-9 For The Treatment Of Hyperkalemia 5/27/2015 6:55:28 AM
Synageva BioPharma (GEVA) Submits Kanuma (Sebelipase Alfa) Application For LAL Deficiency In Japan 5/27/2015 6:38:05 AM
ViiV Healthcare And CHAI Collaboration Delivers Second Milestone With First Filing With The FDA Of Generic Dolutegravir By Aurobindo Pharma (AUROBINDOP.BO) For The Treatment Of HIV 5/26/2015 7:31:55 AM
Wall Street Cheers As Sarepta (SRPT) Soars 50% Premarket on Muscular Dystrophy Drug Filing 5/20/2015 6:01:00 AM
Amgen (AMGN), Sanofi (SAN.PA) in Race to Get European Green light for Anti-Cholesterol Drugs 5/20/2015 10:44:10 AM
KemPharm Completes Pre-NDA Meeting With FDA For KP201/APAP 5/21/2015 11:06:58 AM
Tris Pharma, Inc. Announces The FDA Acceptance Of NDA For Dyanavel XR 5/21/2015 6:26:28 AM
Eagle Pharmaceuticals (EGRX) Submits NDA For Ready-To-Use Bivalirudin To FDA 5/20/2015 11:19:12 AM
Sarepta (SRPT) Announces Plans To Submit Rolling NDA For Eteplirsen Following Today’s Pre-NDA Meeting With The FDA 5/20/2015 6:02:25 AM
Vertex (VRTX) Soars After Hours as FDA Panel Backs Cystic Fibrosis Drug Orkambi 5/12/2015 3:03:44 PM