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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.

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FTC fires shot across pharma's bows over 'improper' patents

The financial regulator in the US has warned the pharma industry that it may consider legal action against companies that improperly list patents in the FDA's 'Orange Book

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Alnylam's Onpattro clears FDA vote for ATTR-cardiomyopathy

Despite a sceptical appraisal by FDA reviewers, Alnylam's Onpattro has been recommended for approval as a treatment for transthyretin amyloidosis cardiomyopathy (ATTR-CM)

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Oral phenylephrine vote may see OTC products pulled in US

An FDA advisory committee has concluded that a commonly used decongestant ingredient used in cold and allergy products does not have any efficacy, raising the possibility

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FDA blocks new use for AstraZeneca's Ultomiris

AstraZeneca has been successful at rolling out its long-acting complement C5 inhibitor Ultomiris in the uses approved for its predecessor Soliris – until now, that is.

FDA panel votes against Intarcia’s GLP-1 implant

FDA capacity forces delay to Iovance's cell therapy

FTC fires shot across pharma's bows over 'improper' patents

Alnylam's Onpattro clears FDA vote for ATTR-cardiomyopathy

Oral phenylephrine vote may see OTC products pulled in US

FDA blocks new use for AstraZeneca's Ultomiris

Amgen's Horizon buyout delivers Sjögren's disease win

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

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