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Articles: Regulatory Issues |
New Drug Application for Exenatide Once Weekly Accepted for Review by FDA
Amylin Pharmaceuticals, 07/08/09
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Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review
Cell Therapeutics, 07/08/09
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King Provides Additional Information on the REMOXY NDA Resubmission Plan
King Pharmaceuticals, 07/08/09
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CareFusion files amended Form 10 Registration Statement with SEC
Cardinal Health, 07/08/09
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Acetaminophen must be made safer, FDA panelists agree
American Pharmacists Association, 07/06/09
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Acura and King Receive FDA Complete Response Letter Regarding Acurox
King Pharmaceuticals, 07/06/09
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Takeda Receives FDA Complete Response Letter for Alogliptin, An Investigational Treatment for Type 2 Diabetes
Takeda Pharmaceuticals North America, 07/02/09 Examination of the Relationship Between Oncology Drug Labeling Revision Frequency and FDA Product Categorization
American Journal of Public Health, 07/01/09 Roche Discontinues and Plans to Delist Accutane in the U.S.
Roche, 07/01/09
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New EU Committee Leaves Member States Out In The Cold
PharmExec, 07/01/09 Biopure Receives Notice of Nasdaq Delisting
BioPure, 07/01/09
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Novartis receives Complete Response letter from the US Food and Drug Administration for its investigational vaccine Menveo
Novartis, 07/01/09
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DFine Europe GmbH Accepts Terms of Preliminary Injuction Issued by German Court for Medtronic GmbH
Medtronic, 06/30/09
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Seretide: Irish patent litigation update
GlaxoSmithKline, 06/29/09
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FDA Tells Drug and Device Makers to Give Balanced Picture of Risks in Ads, Labels
JAMA, 06/29/09 Lundbeck receives FDA Complete Response Letter on Serdolect for the treatment of schizophrenia
Lundbeck, 06/26/09
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CEL-SCI Files Patent Application to Support Company's Treatment for More Virulent Strain of H1N1 Swine and Other Influenza Viruses
CEL-SCI, 06/26/09 eHealth Ontario CEO, Sarah Kramer, is terminated
Canadian Healthcare Technology, 06/26/09
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Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review
Cell Therapeutics, 06/25/09
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Regulatory update for REZONIC (casopitant mesylate)
GlaxoSmithKline, 06/24/09
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