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Abbott's TriClip OK'd for Tricuspid Regurgitation

[ Price : $8.95]

FDA approves Abbotts TriClip, a transcatheter edge-to-edge repair system that is designed for treating tricuspid regurgitation.

FDA Qualifies Lethal Arrhythmia Database

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The FDA Medical Device Development Tool program qualifies the University of California San Francisco Lethal Arrhythmia Database.

FDA OKs Zevtera Antibiotic with 3 Indications

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FDA approves Basilea Pharmaceuticas antibiotic Zevtera for three indications.

Lenz Plans NDA for Presbyopia Eye Drops

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Lenz Therapeutics says it will file an NDA for aceclidine eye drops in a few months after reporting Phase 3 study results for trea...

Prenosis AI Sepsis Predictor Authorized for Use

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FDA grants Prenosis a de novo marketing authorization for its Sepsis ImmunoScore, an artificial intelligence/machine learning soft...

OPQ Supported 55 Novel Drug Approvals in 2023

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The CDER Office of Pharmaceutical Quality outlines its accomplishments in 2023 under four strategic priorities.

More Changes Urged in RRA Revised Guidance Comments

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Several stakeholder organizations say they appreciate that FDA revised its draft guidance on regulatory review assessments and sug...

CGMP Violations at Mexicos Betone SA de CV

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FDA warns Mexicos Betone SA de CV about CGMP violations in its manufacturing of finished drugs.

Multiple Agena Bioscience Violations

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FDA warns San Diego, CA-based Agena Bioscience about multiple violations in its manufacturing of a colon diagnostic panel as part ...

QS Issues in Beckman Coulter Inspection

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FDA warns Beckman Coulter about QS regulation violations at its Chaska, MN, manufacturing facility.