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FDA OKs eNeura Therapeutics Migraine Device

[ Price : $8.95]

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

[ Price : $8.95]

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...

John Taylor Leaving FDA Again

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FDA counselor to the commissioner and Global Regulatory Operations and Policy (GO) acting deputy commissioner John M. Taylor resig...

State AGs Want Zohydro ER Pulled or Reformulated

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Attorneys general from 29 states ask FDA to reconsider its approval of Zogenix Zohydro ER or order it to be reformulated to be abu...

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...

FDA Presents Device Review Assessment

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Federal Register Notice: FDA reveals high priority recommendations from an independent assessment of the device review process.