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DTC Ad Study Finds Benefit/Risk Conflation

[ Price : $8.95]

New studies by FDA drug promotion staff find that consumers conflated a drugs benefits and risks when they were exposed to both a ...

Ionis Upbeat on Angelman Drug Study

[ Price : $8.95]

Ionis Pharmaceuticals reports favorable data from a Phase 1/2 open-label study of ION582 in people with Angelman syndrome.

FDA Clears Latest Ethos Radiotherapy System

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FDA clears a Varian 510(k) for new functionality to its Ethos radiotherapy system for treating cancer.

De Novo Authorization for Allay Nerve Cap

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FDA grants Tulavi Therapeutics a de novo marketing authorization for its Allay Nerve Cap, a surgical hydrogel designed to protect ...

Guide on Pediatric Inflammatory Bowel Disease

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Federal Register notice: FDA makes available a draft guidance entitled Pediatric Inflammatory Bowel Disease: Developing Drugs for ...

Mainz Seeks Breakthrough Status for Colon Cancer Test

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Mainz Biomed files an application requesting a breakthrough device designation for what it calls its non-invasive next-generation ...

Device Chemical Analysis for Biocompatibility

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FDA announces an 11/6 public workshop entitled Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Supp...

Diamyd Granted Fast Track for Diabetes

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FDA awards Diamyd Medical a Fast Track designation for Diamyd (rhGAD65/alum) for use in treating Type 1 diabetes in pediatric pati...

Spectralis Optical Coherence Tomography Module Cleared

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FDA clears a Heidelberg Engineering 510(k) for its Spectralis optical coherence tomography angiography (OCTA) Module with SHIFT te...