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FDA Wants More Data on Janssen Combo Diabetes Drug

[ Price : $8.95]

FDA issues Janssen a complete response letter on its NDA for a fixed-dose combination of canagliflozin and immediate-release metfo...

Cadence Seeks Approval Restrictions on Generic Ofirmev Products

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Cadence Pharmaceuticals petitions FDA asking it not to approve any generic or 505(b)(2) NDAs for an acetaminophen solution for int...

Report Looks at Studies in Comparative Effectiveness

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A new government report examines how observational studies contribute to the results and conclusions in comparative effectiveness ...

FDA OKs eNeura Therapeutics Migraine Device

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FDA approves an eNeura Therapeutics de novo petition to allow marketing of its Cerena Transcranial Magnetic Stimulator, the first ...

PhRMA Seeks More Detail on Antibiotic Non-inferiority Designs

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PhRMA asks FDA to include greater detail on non-inferiority designs that make limited use of statistical inference testing in its ...

Alexion Updates Soliris IV Recall

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Alexion Pharmaceuticals updates a November recall notice for its Soliris Concentrated Sollution IV Infusion to include instruction...

Mallinckrodt Trial of Pain Drug Meets Endpoint

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Mallinckrodt says a Phase 3 efficacy trial of its investigational MNK-155 for managing moderate to severe acute pain has met its p...

Advisors Say Grastek is Safe and Effective

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Members of FDAs Allergenic Products Advisory Committee vote to recommend that Mercks Grastek is safe and effective for treating gr...

FDA Says No Clinical Support for Nipple Aspirate

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FDA tells consumers not to rely on needle aspirate tests as a standalone tool to detect breast cancer.

Guidance on Animal Drugs in Feed and Antimicrobial Use

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Federal Register Notice: FDA releases a guidance on revising conditions of use of new animal drugs administered in feed and to ali...