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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

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$Eko Health and ejection fraction$

FDA clears AI that detects heart failure using a stethoscope

The FDA has cleared an artificial intelligence algorithm that can detect signs of heart failure in seconds using a digital stethoscope during a standard physical exam.

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Aduhelm and an expensive failure to launch

Biogen’s treatment for Alzheimer’s was initially regarded as a major treatment breakthrough.

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

FDA clears AI that detects heart failure using a stethoscope

Aduhelm and an expensive failure to launch

Third Rock in $2bn drug-hunting pact with China's Funnel

Securing your ROI: Turning post-acquisition integration into...

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