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FDA accepts review of SeresTx BLA for oral microbiome therap...

The FDA has accepted for review Seres Therapeutics’ Biologics License Application (BLA) for SER-109, an investigational oral

Views & Analysis

Considerations for Mobile Health Technology Developers: Part...

In Part 1 of this series, general wellness devices and mobile me

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Illustration of a nerve cell on a colored background with light effects

Relief for Amylyx as FDA clears controversial ALS drug Relyv...

Patient organisations have been celebrating the FDA approval yesterday of Amylyx' amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings tha

Views & Analysis

Considerations for Mobile Health Technology Developers: Part...

In Part 1 of this series, general wellness devices and mobile medical applications (MMAs) will be considered. Part 2 of this series will be devoted to clinical decision support (C

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FDA sets out its thinking on protecting children in clinical...

The FDA has published draft guidance giving its position on the ethical reasons for including children in clinical trials, and protecting them from harm.

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FDA's Brendan O'Leary at DtX East in Boston in 2022

FDA drops PreCert report, new digital health guidances

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digit

FDA accepts review of SeresTx BLA for oral microbiome therap...

Considerations for Mobile Health Technology Developers: Part...

Relief for Amylyx as FDA clears controversial ALS drug Relyv...

Considerations for Mobile Health Technology Developers: Part...

FDA sets out its thinking on protecting children in clinical...

FDA drops PreCert report, new digital health guidances

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

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

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