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MHRA pledges two-week review for low-risk clinical trials

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has implemented one part of its plan to reform the regulations governing clinical trials, namely an ini

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FDA will add digital health advisory committee to its roster

The FDA is setting up a new advisory committee to provide independent expertise on the emerging category of technologies like digital therapeutics, virtual and augmented r

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Alnylam’s expansion plan for Onpattro blocked by FDA

Alnylam has abandoned plans to add cardiomyopathy to the label for transthyretin-mediated amyloidosis (ATTR) therapy Onpattro after the FDA turned down its marketing appli

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FDA panel sceptical on Lumakras confirmatory data

An FDA advisory committee has voted that Amgen’s confirmatory phase 3 trial for KRAS inhibitor Lumakras is not enough to support full approval, but it seems unlikely that

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Takeda pulls Exkivity in US after failed confirmatory trial

Takeda has decided to withdraw its cancer drug Exkivity from the market, after a trial that was supposed to confirm its efficacy failed to deliver a positive result.

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FDA turns down Lilly’s eczema drug lebrikizumab

Problems at a contract manufacturing organisation have scuppered Eli Lilly’s hopes of a timely FDA approval for lebrikizumab, its IL-13 inhibitor for the treatment of atop

MHRA pledges two-week review for low-risk clinical trials

FDA will add digital health advisory committee to its roster

Alnylam’s expansion plan for Onpattro blocked by FDA

FDA panel sceptical on Lumakras confirmatory data

Takeda pulls Exkivity in US after failed confirmatory trial

FDA turns down Lilly’s eczema drug lebrikizumab

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