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FTC challenges dozens of ‘improper’ US drug patents

The financial regulator in the US has sent letters to 10 companies that it claims have improperly listed patents in the FDA’s ‘Orange Book’ in order to block generic rival

Market Access

DSCSA & dispensers: In the relay race of compliance, how to ...

Leading up to the end of August, I was looking forward to attending the HDA Traceability Seminar in Washington, DC.

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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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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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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

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FDA panel votes against Intarcia’s GLP-1 implant

Intarcia Therapeutics’ take on the massively successful GLP-1 agonist class of diabetes drugs has failed to convince an FDA advisory committee, which voted unanimously aga

FTC challenges dozens of ‘improper’ US drug patents

DSCSA & dispensers: In the relay race of compliance, how to ...

FDA will add digital health advisory committee to its roster

FDA panel sceptical on Lumakras confirmatory data

FDA turns down Lilly’s eczema drug lebrikizumab

FDA panel votes against Intarcia’s GLP-1 implant

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

How to meet your physicians where they are online

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