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High Court Mixed on Changing Federal Circuits Role in Patent Appeals

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The U.S. Supreme Court expresses mixed reactions to whether the Federal Circuit Court of Appeals should continue to be given leewa...

Spectrum Wants Fusilev Approval Date, Exclusivity Extended

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Spectrum asks FDA to extend the approval date and orphan drug expiration date for its Fusilev to account for the delay in launch c...

Advisors Asked About Cosentyx Efficacy, Safety

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FDA medical reviewers tell the Dermatologic and Ophthalmic Drugs Advisory Committee that Novartis data show a favorable benefit-ri...

Comments Sought on Consumer Tobacco Panel

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Federal Register Notice: FDA seeks comments on establishing a probability-based panel of tobacco users.

FDA Sends Collection of Info on Device Tracking to OMB

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Federal Register Notice: FDA submits a proposed collection of information on medical device tracking to the Office of Management a...

FDA Panel Votes to Retain Chantix Boxed Warning

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A joint FDA advisory committee votes to recommend retaining a boxed warning on Pfizers smoking cessation drug Chantix (varenicline...

County Health System Wants Clozapine REMS Changed

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Michigans Genesee County Health System asks FDA to revise the clozapine REMS so the drug can be used in African-American patients ...

Court Says Branded Drug Design Defects Preempted

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An Ohio federal judge says that Johnson & Johnson could not comply with a Georgia law requirement to change the composition of its...

Orphan Drug Status for OctreoPharm Tumor Drug

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FDA grants OctreoPharm Sciences an orphan drug designation for its new radiotracer OPS202, indicated for managing neuroendocrine t...

FDA Refuse-to-File Letter for Insys Dronabinol

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FDA issues Insys Therapeutics a Refuse-to-File letter for its proprietary dronabinol oral solution because it provided an inadequa...