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