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Biolinq Gets De Novo for Glucose Sensor

[ Price : $8.95]

FDA grants Biolinq a de novo authorization for its Shine system, said to be the first fully autonomous, needle-free glucose sensor...

Cellebration Refusing to Provide Records to FDA

[ Price : $8.95]

FDA warns San Juan, Puerto Rico-based Cellebration LLC that it is violating the Federal Food, Drug, and Cosmetic Act and agency re...

Acadias Phase 3 Trial of Intranasal Carbetocin Fails

[ Price : $8.95]

Acadia Pharmaceuticals says it will cease developing intranasal carbetocin after its Phase 3 COMPASS PWS trial of the drug for tre...

Regenerative Therapies Expedited Programs

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FDA publishes a draft guidance with recommendations for expedited development and review of regenerative medicine therapies for se...

CGT Trial Innovative Designs Guidance

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FDA publishes a draft guidance on agency requirements and considerations for using various clinical trial designs and endpoints to...

Interchangeable Biosimilar Bill Introduced

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Reps. Pfluger and Landsman introduce bipartisan legislation to deem biosimilars to be interchangeable upon FDA approval.

uniQure Reports Favorable Data in Huntingtons Trial

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uniQure reports favorable data on its investigational gene therapy AMT-130 in Huntingtons disease patients.

University of Texas Clinical Trial Issues

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FDA warns Dr. Ralph DeFronzo about violations in his work as a clinical investigator for two trial protocols at the University of ...

Harmony Reports Disappointing Fragile X Data

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Harmony Biosciences reports topline results from a Phase 3 registrational clinical trial of ZYN002 in Fragile X syndrome did not m...

Cell/Gene Therapy Postapproval Monitoring Guide

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FDA posts a draft guidance outlining methods drugmakers should use to collect long-term safety and efficacy data once cell and gen...