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Spinologics Gets Breakthrough for Spine Device

[ Price : $8.95]

FDA grants Spinologics a breakthrough device designation for its MIScoli system, a vertebral body tethering device to treat scolio...

Roche EUA for Covid Test on Liat System

[ Price : $8.95]

FDA grants Roche an emergency use authorization for its cobas SARS-CoV-2 nucleic acid test for use on the cobas Liat System.

OrphaZyme Gets Complete Response on Arimoclomol

[ Price : $8.95]

FDA sends Orphazyme a complete response letter on an NDA for arimoclomol, a heat shock protein amplifier intended for treating Nie...

Guide on Premenopausal Women with Breast Cancer

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Premenopausal Women with Breast Cancer: Developing Drugs fo...

Progressive Multifocal Leukoencephalopathy Trials Workshop

[ Price : $8.95]

Federal Register notice: FDA announces a 9/21 public workshop entitled Considerations for Progressive Multifocal Leukoencephalopat...

Bausch Health Wants Duobrii ANDA Restrictions

[ Price : $8.95]

Bausch Health petitions FDA to apply its specified bioequivalence and pharmaceutical equivalence criteria to the approval of any A...

Medical Device Remanufacturing Draft Guidance

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FDA issues a draft guidance to clarify whether activities performed on medical devices are likely remanufacturing.

Philips Sound Abatement Foam Recall Notification

[ Price : $8.95]

FDA says Philips has notified customers about possible risks associated with the sound abatement foam used in three of its product...

FDA Accepts AcelRx Dsuvia Promotion Correction Plan

[ Price : $8.95]

FDA accepts AcelRxs plans to update Dsuvia promotional materials that were the subject of an agency Warning Letter.

Medtronic Angiographic Guidewire Component Recall is Class 1

[ Price : $8.95]

FDA says a Medtronic recall of 55,000 angiographic guidewire components is Class 1.