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AZ first to AKT finish line, but FDA clears narrow label

AstraZeneca has claimed FDA approval for its first-in-class pan-AKT inhibitor capivasertib, getting a green light for the drug as a treatment for breast cancer, but with a

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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

AZ first to AKT finish line, but FDA clears narrow label

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

Pharma leaders urge Europe to halt 'slow agony' of decline

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

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