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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

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FDA capacity forces delay to Iovance's cell therapy

Iovance Biotherapeutics is facing a three-month delay in the review of its lifileucel cell therapy for melanoma in the US, held up by "insufficient resources" at the FDA.

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

FDA capacity forces delay to Iovance's cell therapy

CDC panel votes to scrap hepatitis B birth dose advice

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