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Clinical - BLA/NDA/ANDA
Apotex Inc. Announces FDA Has Accepted For Filing Its Biosimilar Application For Pegfilgrastim 12/17/2014 9:16:55 AM
Pozen, Inc. (POZN) Crashes As FDA Rejects Two Forms Of Its Lead Drug Yosprala 12/17/2014 5:57:38 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
Jazz Pharmaceuticals (JAZZ) Initiates Rolling NDA Submission For Defibrotide For The Treatment Of Severe Hepatic Veno-Occlusive Disease 12/12/2014 7:36:03 AM
Supernus Pharmaceuticals (SUPN) Announces Paragraph IV ANDA Filing for Oxtellar XR® 12/10/2014 7:06:46 AM
Aprecia Pharmaceuticals Receives FDA Acceptance For Filing For First Product Using Advanced Zipdose® Technology 12/9/2014 11:15:26 AM
Supernus Pharmaceuticals (SUPN) Announces Paragraph IV ANDA Filing for Trokendi XR® 12/9/2014 10:54:54 AM