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FDA Approves Aptiom for Partial Seizures

[ Price : $8.95]

FDA approves a Sunovion NDA for Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epileps...

FDA Reviewers Slam Genzyme sBLA Submission for Lemtrada

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FDA reviewers say data in a Genzyme supplemental BLA for Lemtrada (alemtuzumab), indicated for treating patients with relapsing fo...

Info on Animal Feed Standards Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on draft animal feed standards to the Office of Manageme...

Workshop on Sentinel Initiative

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Federal Register Notice: FDA plans a public workshop 1/14/14, Sixth Annual Sentinel Initiative in Washington, DC.

FDA Approves LIA Software for Non-Medtronic Leads

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FDA approves Medtronic Lead Integrity Alert software for use with non-Medtronic defibrillator leads.

Activity Found in Genetic Pathway for Pediatric Tumors

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Researchers at Johns Hopkins find a known genetic pathway to be active in many difficult-to-treat pediatric brain tumors called lo...

Aeterna Zentaris Submits NDA for Growth Hormone Drug

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Aeterna Zentaris submits an NDA to FDA for macimorelin acetate to induce growth hormone release to evaluate adult growth hormone d...

FDA Funds Study on Generic Transplant Drug Equivalence

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FDA agrees to fund studies at the University of Cincinnati to evaluate the safety and efficacy of a generic immunosuppressive drug...

FDA Speakers Update Agency Cancer Efforts

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FDAers Richard Pazdur and Liz Mansfield update the Institute of Medicines National Cancer Policy Summit on some CDER and CDRH acti...

Guidance on Hearing Devices

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Federal Register Notice: FDA releases a draft guidance on Regulatory Requirements for Hearing Aid Devices and Personal Sound Ampli...