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FDA Approves Bystolic, a Novel Beta Blocker
Forest Laboratories and Mylan announced that the novel beta blocker Bystolic (nebivolol) was approved by the U.S. Food and Drug Administration (FDA) f...

FDA and Pharsight Continue to Collaborate Under CRADA
Pharsight Corporation, provider of software, strategic consulting, and regulatory services for optimizing clinical drug development, today provided an...

FDA Reviewing Potential Anti-Arrhythmic Claims for Ranexa
CV Therapeutics, announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it will evaluate the approval of potential a...

FDA Launches E-mail Alert Subscription Service through Public Web site
The U.S. Food and Drug Administration today announced a new e-mail service that alerts subscribers whenever information is updated on certain FDA Web ...

FDA Okays Cymbalta for Maintenance Treatment of Major Depressive Disorder
Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA)has approved Cymbalta (duloxetine HCl) for the maintenance treatment o...

FDA Chooses Genedata Bioinformatics Platform
Genedata, provider of in silico solutions for the pharmaceutical and life sciences industries, announced an agreement with the National Center for To...

Leading U.S. Physician Criticizes Delaying FDA Sunscreen Labeling Decision For Another Month
The U.S. Food and Drug Administration on Tuesday delayed its decision on adopting a new rule and rating system for over-the-counter sunscreen products...

Biomarin Files New Drug Application with US FDA for its PEG-PAL Drug
Biomarin Pharmaceutical announced that it has filed an investigational new drug application with the US Food and Drug Administration for its PEG-PAL d...

Proposed Sunscreen Rule Gets Extended Comment Period from FDA
The Food and Drug Administration announced that it will be extending the comment period on the agency's proposed sunscreen regulation to Dec. 26, 2007...

FDA Approves Zyrtec for Nonprescription Use in Adults and Children
The U.S. Food and Drug Administration has approved tablet, chewable tablet, and syrup formulations of Zyrtec (cetirizine HCl) for nonprescription use....

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