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FDA approves Abbotts TriClip, a transcatheter edge-to-edge repair system that is designed for treating tricuspid regurgitation.[ Price : $8.95]
The FDA Medical Device Development Tool program qualifies the University of California San Francisco Lethal Arrhythmia Database.[ Price : $8.95]
FDA approves Basilea Pharmaceuticas antibiotic Zevtera for three indications.[ Price : $8.95]
Lenz Therapeutics says it will file an NDA for aceclidine eye drops in a few months after reporting Phase 3 study results for trea...[ Price : $8.95]
FDA grants Prenosis a de novo marketing authorization for its Sepsis ImmunoScore, an artificial intelligence/machine learning soft...[ Price : $8.95]
The CDER Office of Pharmaceutical Quality outlines its accomplishments in 2023 under four strategic priorities.[ Price : $8.95]
Several stakeholder organizations say they appreciate that FDA revised its draft guidance on regulatory review assessments and sug...[ Price : $8.95]
FDA warns Mexicos Betone SA de CV about CGMP violations in its manufacturing of finished drugs.