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5 Teva ProAir Patents Ordered Out of Orange Book

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A New Jersey federal judge orders five Teva ProAir patents removed from the FDA Orange Book.

FDA Platform Technology Designation Analyzed

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Two Morgan Lewis attorneys analyze a recent FDA guidance on how it will implement its drug platform technology designation program...

Positive Results for Setrusumab in Bone Disease

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Ultragenyx and BioMereo say their setrusumab showed positive results in the Phase 2 portion of the Orbit study in patients with th...

FDA OKs Lillys Retevmo for Some Thyroid Cancers

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FDA gives traditional approval to Lillys Retevmo for some thyroid cancers in patients aged two and up.

Appropriators Slash FDA Budget by $450 Million

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A House Appropriations subcommittee slashes $450 million (6%) from FDAs fiscal year 2025 budget.

FDA Clears Avicenna.AIs Vertebral Fracture Detector

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FDA clears an Avicenna.AI 510(k) for its CINA-VCF, a triage and notification artificial intelligence tool for detecting unsuspecte...

Getinge Clinical Decision Support Software Cleared

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FDA clears a Getinge 510(k) for its innovative clinical decision support software Talis +ACG (Advanced Clinical Guidance).

Spinal Simplicity Anterior Cervical Plate Cleared

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FDA clears a Spinal Simplicity 510(k) for its Wolffs Law Anterior Cervical Plate System.

CGMP Violations at Malaysias TCT Neutraceuticals

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FDA warns Malaysias TCT Neutraceuticals about CGMP violations in its manufacturing of OTC drugs.

CDER AI Pharmacovigilance Meeting Program

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Federal Register notice: CDER announces the Emerging Drug Safety Technology Meeting program for stakeholders to discuss the use of...