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Clinical - BLA/NDA/ANDA
Baxter International, Inc. (BAX) Submits Application For U.S. FDA Approval Of BAX111, Investigational Recombinant Treatment For Von Willebrand Disease 12/22/2014 11:08:19 AM
Ligand Pharmaceuticals Inc. (LGND) Partner GlaxoSmithKline (GSK) Announces US Regulatory Submission Seeking Additional Indication For Promacta® 12/22/2014 11:05:07 AM
Jaguar Animal Health Initiates Filing Of Its First New Animal Drug Application With FDA 12/22/2014 11:03:10 AM
Taiho Oncology Completes Submission Of TAS-102 New Drug Application To The US FDA For The Treatment Of Refractory Metastatic Colorectal Cancer 12/22/2014 8:17:50 AM
Pozen, Inc. (POZN) Crashes As FDA Rejects Two Forms Of Its Lead Drug Yosprala 12/17/2014 5:57:38 AM
Apotex Inc. Announces FDA Has Accepted For Filing Its Biosimilar Application For Pegfilgrastim 12/17/2014 9:16:55 AM
Bayer HealthCare (BAY) Submits Biologics License Application For BAY 81-8973 For The Treatment Of Hemophilia A In Adults And Children 12/17/2014 8:50:27 AM
Pozen, Inc. (POZN)’s YOSPRALA™ Receives Complete Response Letter From The FDA 12/17/2014 5:58:52 AM
Genentech (RHHBY) Submits NDA For Skin Cancer Med Cobimetinib 12/15/2014 6:01:59 AM
CSL Behring Submits Biologics License Application For FDA Approval Of Recombinant Fusion Protein Linking Coagulation Factor IX With Recombinant Albumin (Rix-FP) For Hemophilia B Patients 12/16/2014 8:36:38 AM
Relypsa, Inc. (RLYP) Announces FDA Acceptance Of New Drug Application For Patiromer For Oral Suspension To Treat Hyperkalemia 12/15/2014 7:23:13 AM
Collegium Pharmaceutical, Inc. Submits New Drug Application For Xtampza™ ER (Oxycodone Extended-Release); Its Abuse-Deterrent, Extended-Release Analgesic For The Treatment Of Chronic Pain 12/15/2014 9:26:19 AM
Otsuka America Pharmaceutical, Inc. And H. Lundbeck A/S (LUN.CO) Release: U.S. FDA Accepts For Review Supplemental New Drug Application For Deltoid Administration Of Abilify Maintena® (Aripiprazole) Extended-Release Injectable Suspension 12/15/2014 10:13:44 AM
FDA Confirms Lipocine Inc. (LPCN)'s Previously-Agreed Clinical Development Plan For LPCN 1021 12/15/2014 7:26:16 AM
Genentech (RHHBY) Submits New Drug Application To FDA For Investigational Cobimetinib Used In Combination With Zelboraf (Vemurafenib) In Advanced Melanoma 12/15/2014 6:02:57 AM