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FDA sets June adcomm date for Lilly’s Alzheimer’s drug

The FDA has confirmed that it will convene an advisory committee meeting on 10th June to discuss Eli Lilly’s Alzheimer’s disease candidate donanemab, after announcing a de

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Apple gets FDA okay to use AFib tool in clinical trials

The atrial fibrillation (AFib) detection feature on Apple Watch devices has become the first digital health technology to be qualified under a programme recently introduce

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Final FDA rule on LDTs creates a paradigm shift for laborato...

WASHINGTON, D.C., April 30, 2024 –The Food and Drug Administration’s (FDA) final rule has reclassified laboratory developed tests (LDTs) as medical devices, according to Avalere.

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X4 Pharma gets first FDA okay for WHIM syndrome drug

Patients in the US with the ultra-rare disease WHIM syndrome now have their first approved treatment, after X4 Pharma’s Xolremdi was given a green light by the FDA.

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FDA initiative puts AR/VR at heart of home health drive

A new programme announced by the FDA will work towards the use of augmented reality and virtual reality (AR/VR) to make patients’ own homes an integral part of the healthc

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Study points to weaknesses in FDA accelerated approval path

Less than half of the cancer therapies that were granted accelerated approval by the FDA between 2013 and 2017 showed a clinical benefit in a confirmatory trial within the

FDA sets June adcomm date for Lilly’s Alzheimer’s drug

Apple gets FDA okay to use AFib tool in clinical trials

Final FDA rule on LDTs creates a paradigm shift for laborato...

X4 Pharma gets first FDA okay for WHIM syndrome drug

FDA initiative puts AR/VR at heart of home health drive

Study points to weaknesses in FDA accelerated approval path

The long-delayed promise of the microbiome, with Sam Possemi...

How to meet your physicians where they are online

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