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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'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

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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The FDA has published draft guidance giving its position on the ethical reasons for including children in clinical trials, and protecting them from harm.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 panel shoots down Spectrum, Oncopeptides' cancer drugs

Chances of FDA approval for Spectrum Pharma's lung cancer candidate poziotinib and Oncopeptides' Pepaxto for multiple myeloma have taken a dive, after the regulator's expert advisors voted

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Helping to support momentum on antimicrobial innovation

Undeterred by FDA setback, GSK snaps up Spero antibiotic

GSK is paying $66 million upfront to license rights to Spero Therapeutics novel antibiotic tebipenem Hbr, unswayed by the FDA's decision earlier this year not to approve the drug for adults

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GSK's daprodustat will have to face FDA advisory committee

GSK has said that its daprodustat for anaemia associated with chronic kidney disease (CKD) will have to face an FDA advisory committee before the US regulator delivers a verdict on the drug

Considerations for Mobile Health Technology Developers: Part...

FDA drops PreCert report, new digital health guidances

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

FDA panel shoots down Spectrum, Oncopeptides' cancer drugs

Undeterred by FDA setback, GSK snaps up Spero antibiotic

GSK's daprodustat will have to face FDA advisory committee

Roche, Viking, and Syntis showcase obesity drug candidates

Discover a new era of healthcare panel engagement: Grounded ...

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