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QS, MDR Issues at Taiwans Visgeneer

[ Price : $8.95]

FDA warns Taiwans Visgeneer, Inc., about Quality System and Medical Device Reporting violations in its manufacturing of blood gluc...

Medical Device PFAS Appear Safe: FDA

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FDA issues an online post describing the safety to patients of the type of PFAS used in medical devices.

BMS Files Breyanzi Marginal Zone Lymphoma sBLA

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FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Breyanzi (lisocabtagene maraleucel; liso-cel) as a pot...

Lantheus NDA for Pylarify New Formulation

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FDA accepts a Lantheus NDA for a new formulation of its Pylarify F 18 prostate-specific membrane antigen imaging agent.

Alert on Boston Scientific Defibrillation Leads

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FDA issues an early alert based on a Boston Scientific letter to customers about certain Endotak Reliance defibrillation leads tha...

FDA Early Alert on Watchman Devices

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FDA issues an alert after Boston Scientific notified customers that all lots of certain Watchman Access Systems have updated use i...

Quarantine Some Medline ReNewal Catheters

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An FDA Early Alert says Medline ReNewal recommends that some reprocessed St. Jude electrophysiology catheters be quarantined due t...

FDA Accelerated Approval for Jazz Modeyso

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FDA grants accelerated approval for Jazz Modeyso to treat diffuse midline glioma.

FDA Publishes Data Standards Program Update

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FDA publishes the FY 2025 Quarter 2 update to the CBER/CDER Data Standards Program Action Plan.

Clarametyx Gets Fast Track for Pulmonary Infection Drug

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FDA grants Clarametyx Biosciences both fast track and qualified infectious disease product designations for its lead therapeutic c...