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Molecular entity
Results: 27

#	Item
11	CY 2013 CDER New Molecular Entity (NME) & New BLA Calendar Year Approvals As of December 31, 2013 This report reflects the data shown as it is identified in the database. Selection Criteria: User Response: Start Date: 1/ Add to Reading List Source URL: www.fda.gov Language: English Trastuzumab Melanoma Chronic Medicine Pharmaceutical industry Genentech South San Francisco California Gilead Sciences
12	CDER New Molecular Entity (NME) Drug and New Biologic Approvals for Calendar Year 2008 Updated through December 31, 2008 NME New Drug Application (NDA) Approvals: Application Type Add to Reading List Source URL: www.fda.gov Language: English Organofluorides HIV/AIDS Opioids Phenols Tapentadol Rufinamide Clevidipine HIV Bendamustine Chemistry Organic chemistry Organochlorides
13	CDER New Molecular Entity (NME) & New BLA Calendar Year Approvals As of December 31, 2012 Selection Criteria: User Response: Start Date: [removed] Add to Reading List Source URL: www.fda.gov Language: English Benzamides Piperazines Orphan drugs Organofluorides Kidney cancer Ponatinib Omacetaxine mepesuccinate Chronic myelogenous leukemia Renal cell carcinoma Medicine Oncology Chemistry
14	CDER New Molecular Entity (NME) and New Biologic Approvals Calendar Year 2011 Add to Reading List Source URL: www.fda.gov Language: English Antivirals Amines Quinazolines Pyrazines Telaprevir Ribavirin Boceprevir Acute exacerbation of chronic obstructive pulmonary disease Vandetanib Chemistry Protease inhibitors Organic chemistry
15	CDER New Molecular Entity (NME)/ New BLA Calendar Year Approvals As of December 31, 2009 Add to Reading List Source URL: www.fda.gov Language: English Immunosuppressants Centocor Ustekinumab Celgene Febuxostat Pharmacology Chemistry Organic chemistry Carboxylic acids
16	Title: Sex Differences in Pharmacokinetics, Efficacy and Safety of New Molecular Entity Drugs and Biologics approved by the FDA from 2007 to 2009 Add to Reading List Source URL: www.fda.gov Language: English Clinical pharmacology Food and Drug Administration Therapeutics United States Public Health Service Medicinal chemistry Pharmacology Pharmaceutical sciences Clinical research
17	CDER New Molecular Entity (NME) & New BLA Calendar Year Approvals As of December 31, 2010 Add to Reading List Source URL: www.fda.gov Language: English Eisai Chemistry Organic chemistry Eribulin Ceftaroline fosamil
18	New Molecular Entity 2010 Statistics Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmaceutical industry Clinical pharmacology Center for Drug Evaluation and Research New Drug Application Biologic Drug discovery Pharmaceutical sciences Food and Drug Administration Pharmacology
19	Survey of the Presentation of Sex Analysis in the FDA Review of Efficacy and Safety Clinical Data of New Molecular Entity Drugs and Biologics Approved From 2007 to 2009 Onyeka Otugo1, Rita Poon1, Vanessa Copeland1, Kesha Add to Reading List Source URL: www.fda.gov Language: English Research Food and Drug Administration Pharmacology New Drug Application Milnacipran Clinical trial Approved drug FDA Special Protocol Assessment Prescription Drug User Fee Act Pharmaceutical sciences Clinical research Pharmaceutical industry
20	Participation of Women and Racial Minorities in Late Phase Clinical Trials of New Molecular Entity Drugs and Biologics Approved by the Food and Drug Administration between[removed] Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Medicine Clinical research Clinical pharmacology Center for Drug Evaluation and Research Biologic New Drug Application Drug discovery New chemical entity Pharmaceutical sciences Food and Drug Administration Pharmacology

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