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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.

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FDA sets out its thinking on psychedelic drug trials

The FDA has published its first-ever guidance document on clinical trials with psychedelic drugs, an emerging treatment category for psychiatric and substance use disorder

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FDA panel vote dashes Intercept’s NASH hopes

Intercept Pharma is facing an uphill battle to get FDA approval of its OCA therapy for non-alcoholic steatohepatitis (NASH) once again, after FDA advisors comprehensively

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

FDA sets out its thinking on psychedelic drug trials

FDA panel vote dashes Intercept’s NASH hopes

CDC panel votes to scrap hepatitis B birth dose advice

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