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Medtronic Wins Expanded Use for Evolut Aortic Valve

[ Price : $8.95]

FDA approves an expanded use for Medtronics Evolut transcatheter aortic valve replacement system, allowing implantation of a new E...

Ambu Recalls its SPUR II Resuscitators

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Ambu recalls (Class 1) its SPUR II resuscitators due to the manometer port being blocked, which causes the manometer to become non...

Complete Response on Telix PET Imaging Agent

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FDA issues Telix Pharmaceuticals a complete response letter for its BLA seeking approval of Zircaix (89Zr-DFO-girentuximab), an in...

FDA Rejects Outlooks Wet AMD Drug Again

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FDA sends Outlook Therapeutics a complete response letter on its resubmitted BLA for Lytenava (bevacizumab-vikg) for wet age-relat...

AdventaPharma Wants Generic Ozempic Conditions

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AdventaPharma asks FDA to impose conditions on ANDAs referencing Ozempic to ensure an equivalent pen injector and active pharmaceu...

Bayer NDA Accepted for Next-Gen Contrast Agent

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FDA accepts Bayers NDA for gadoquatrane, a next-generation gadolinium-based contrast agent for use in magnetic resonance imaging.

Sen. Cassidy Seeks Postponement of Vaccine Panel

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In the wake of CDC director Susan Monarezs firing, Senate HELP Committee chair Bill Cassidy (R-LA) calls on HHS to postpone a just...

FDA Recommends More Leqembi MRIs

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FDA says it is requiring a change in labeling for Eisai/Biogens Alzheimers drug Leqembi to call for an earlier MRI monitoring scan...

FDA-483 on IntegraDose Inspection

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FDA releases the form FDA-483 with six observations from an inspection at the Minneapolis, MN-based IntegraDose Compounding Servic...

Integra Recalls Surgical Applicators Over Sterility Issues

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Integra LifeSciences recalls (Class 1) its Extended Tip Applicators due to sterility concerns.