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Latest From Sue Sutter
US agency’s advisory committees will consider whether ongoing trial of exon 45- and 53-skipping compounds for Duchenne muscular dystrophy should allow use of in-dwelling ports to aid infusion.
Infliximab-abda gains FDA licensure without having faced an advisory committee review; under current case law, launch could come as early as mid-October.
US agency is convening two-day workshop on federal efforts to support healthcare provider education about pain management and safe use of the drugs; two University of Washington researchers say agency needs to exercise stricter oversight of opioid marketing and promotion.
US FDA drug reviewers argue that enrolling more heterogeneous patient populations could result in fewer postmarketing requirements and earlier satisfaction of pediatric study obligations.
Sandoz’s and Amgen’s biosimilars employ autoinjectors that are currently used with the sponsors’ novel biologic products, allowing them to avoid additional human factors study testing of the delivery devices.
Drug Review Profile of TNF-inhibitor etanercept-szzs examines how US FDA navigated its way around ‘inaccurate’ pediatric psoriasis labeling for the reference product, Amgen’s Enbrel, to reflect current state of the knowledge on the biosimilar’s labeling, albeit only temporarily.