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FDA Clears Difusion Tech Xiphos for Degenerative Disc

[ Price : $8.95]

FDA clears a Difusion Technologies 510(k) for the Xiphos line of posterior interbody devices.

FDAs Slow Pace of Change Concerns Top Side

[ Price : $8.95]

A New England Journal of Medicine analysis of the first year of FDAs new leadership says commissioner Margaret Hamburg and princip...

FDA Issues URL Guidance

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FDA issues a guidance recommending that manufacturers add URLs to electronic product labeling.

Integra Spinal Fusion Device Cleared

[ Price : $8.95]

FDA clears an Integra LifeSciences 510(k) for its Vu aPOD Prime anterior lumbar interbody fusion device.

FDA Grants $900K for PAHO Information Hub

[ Price : $8.95]

FDA says it has awarded a $904,000 cooperative agreement grant to the Pan American Health Organization to research and develop an ...

Symphogen/Swedish Orphan Product Gets Orphan Status for ITP

[ Price : $8.95]

FDA grants orphan drug status to Symphogen and Swedish Orphan Biovitrums rozrolimupab (Sym001) for treating primary Immune Thrombo...

Baxter Reports Phase 3 Analyses of HyQ Immune Globulin Therapy

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Baxter reports under-skin infusion comparability to IV in a Phase 3 trial of its immune globulin therapy HyQ.

Will High Court Hear Exclusivity Case?

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Apotex asks the Supreme Court to review an appeals court ruling giving Teva 180-days of marketing exclusivity for generic losartan...

Axcan Shortage with Photofrin for Injection

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FDA says Axcan is experiencing a product shortage with Photofrin (porfimer sodium) injection because a pending supplement is under...

FDA Clears Stalif Midline Lumbar Fusion System

[ Price : $8.95]

FDA clears a Centinel Spine 510(k) for the Stalif Midline system intended for use in anterior lumbar interbody fusion.