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Clinical - BLA/NDA/ANDA
Analyst Says FDA Panel Lukewarm on Amgen (AMGN) Cancer Drug, As Company Deals With Split Personality 4/30/2015 10:06:19 AM
Amgen (AMGN)’s T-Vec Cancer Therapy Gets FDA Panel OK 4/30/2015 7:11:41 AM
Amerigen Pharmaceuticals Announces Tentative Approval Of Generic Toviaz 4/30/2015 11:19:30 AM
Amgen (AMGN) To Discuss Details Of The Biologics License Application For Talimogene Laherparepvec For Patients With Metastatic Melanoma 4/29/2015 6:43:36 AM
AstraZeneca PLC (AZN) Release: FDA Grants Priority Review For Potential New Indication For BRILINTA 4/29/2015 9:39:07 AM
Prior to FDA Vote, Advisory Committee Cites Study Bias Concerns Over Amgen (AMGN) Cancer Vaccine 4/27/2015 6:46:34 AM
Biogen (BIIB) Release: FDA Accepts Biologics License Application For ZINBRYTA (Daclizumab High-Yield Process) For Treatment Of MS 4/29/2015 10:07:34 AM
IGI Laboratories, Inc. Announces Second ANDA Submission Of 2015 4/29/2015 6:56:51 AM
PharmaEngine, Inc. Announces Merrimack (MACK) Completed MM-398 (PEP02) New Drug Application Submission To U.S. FDA 4/28/2015 10:37:15 AM
Otonomy, Inc. (OTIC) Announces FDA Acceptance of AuriPro New Drug Application 4/28/2015 7:47:04 AM
Merrimack (MACK) And Baxter BioScience Corporation (BAX) Announce Completion Of New Drug Application Submission To U.S. FDA For MM-398 As A Treatment For Post-Gemcitabine Metastatic Pancreatic Cancer 4/27/2015 6:53:49 AM
CureDuchenne Celebrates Submission Of First-Ever New Drug Application For Duchenne Muscular Dystrophy Amenable To Exon 51 Skipping; Cureduchenne Was Early Funder Of Drisapersen’s Development 4/27/2015 10:26:31 AM
BioMarin (BMRN) Completes Rolling NDA Submission To FDA For Drisapersen For Treatment Of Duchenne Muscular Dystrophy Amenable To Exon 51 Skipping 4/27/2015 7:52:06 AM
U.S. FDA Grants Priority Review To AbbVie (ABBV) For Investigational, All-Oral, Interferon-Free Therapy For The Treatment Of Genotype 4 Chronic Hepatitis C 4/24/2015 9:31:25 AM
Bristol-Myers Squibb (BMY) Receives Positive CHMP Opinion In The European Union For Opdivo (Nivolumab) For The Treatment Of Advanced Melanoma In Both First-Line And Previously Treated Patients 4/24/2015 8:32:42 AM