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Hamilton Medical Ventilators Recalled

[ Price : $8.95]

Hamilton Medical recalls its Hamilton-C1, T1, MR-1 ventilators because the capacitators may leak electrolyte fluid onto the ventil...

Courts Could Cut FDA Labeling Enforcement: Avorn

[ Price : $8.95]

Harvard Medical School professor Jerry Avorn says recent court decisions banning compelled speech could be interpreted to stop FDA...

FCA Cases Look at Cybersecurity: Attorneys

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Seven Gibson Dunn attorneys say the government is pursuing False Claims Act cases involving cybersecurity claims by device manufac...

BrainStorm Pulls NurOwn BLA

[ Price : $8.95]

BrainStorm Cell Therapeutics says it is withdrawing a BLA for its NurOwn ALS treatment technology and will work with FDA on a path...

FDA Posts 6 Approved Info Collections

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Federal Register notice: FDA posts a list of six information collections that have been approved by OMB.

Naropin Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Fresenius Kabi USAs Naropin (ropivacaine HCl) solution was not withdrawn due to safet...

Non-Invasive Monitoring Enforcement Guide

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FDA publishes an immediately effective guidance removing an expiration for some enforcement policies for certain non-invasive remo...

FDA Approves UCBs Psoriasis Therapy

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FDA approves a UCB BLA for Bimzelx (bimekizumab-bkzx) for treating moderate-to-severe plaque psoriasis in adults who are candidate...

FDA Clears Intellia IND for Phase 3 Trial

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FDA clears an Intellia Therapeutics IND to permit a Phase 3 trial of its NTLA-2001 to treat transthyretin amyloidosis with cardiom...

FDA Clears GE Pulse Imaging System

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FDA clears a GE HealthCare 510(k) for its Allia IGS Pulse imaging system.