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Megadyne Recalls Pediatric Return Electrodes

[ Price : $8.95]

Megadyne recalls its Megadyne Mega Soft Pediatric Patient Return Electrodes after receiving reports about patients being burned du...

Submit Long Covid Drug as IND: FDA

[ Price : $8.95]

FDA says Revive Therapeutics should submit an IND for a clinical trial of its bucillamine as a treatment for Long Covid.

Drug Distribution Security Comment Period Reopened

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Federal Register notice: FDA reopens the comment period on an 11/20/2023 request for information that is intended to better unders...

Info Collection on Drug Compounding

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Federal Register notice: FDA seeks comments on an information collection extension entitled Human Drug Compounding, Repackaging, a...

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...