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FDA Gene Therapy Panel Research Update

[ Price : $8.95]

Federal Register notice: FDA announces a 5/8 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to hear research upda...

HHS Hit By Cyberattack to Disrupt Virus Actions

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The U.S. government warns that a 3/15 cyberattack against Health and Human Services computer systems was part of a disinformation ...

FDA Lifts Clinical Hold on Unum Therapy

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FDA lifts a partial clinical hold against a Unum Therapeutics Phase 1 trial involving ACTR707 in combination with rituximab in pat...

Thermo Fisher Gets Fast EUA for Coronavirus Test

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FDA issues the fourth coronavirus Emergency Use Authorization to Thermo Fisher for its TaqPath COVID-19 Combo Kit diagnostic.

Endologix PMA OKd for Abdominal Stent Graft

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FDA approves an Endologix PMA Alto Abdominal Stent Graft System (Alto) for endovascular abdominal aortic aneurysm repair.

Sen. Warner Wants Drug Making Moved Back to U.S

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Sen. Mark Warner (D-VA) writes HHS urging it to develop a long-term plan to move pharmaceutical manufacturing back to the U.S. to ...

Guide on Rare Diseases with Substrate Deposition

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FDA posts a final guidance on slowly progressive, low-prevalence rare diseases with substrate deposition that result from single e...

TransEnterix 510(k) for Intelligent Surgical Unit

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FDA clears a TransEnterix 510(k) for the Intelligent Surgical Unit (ISU) that enables machine vision capabilities on the Senhance ...

Panel to Review TransMedics Organ Care System

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Federal Register notice: FDA announces a 4/16 Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting t...

Final Guide on Biological Deviation Reporting

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Federal Register notice: FDA makes available a final guidance entitled Biological Product Deviation Reporting for Blood and Plasma...