Insulet initiates a Class 1 device correction for certain lots of its Omnipod 5 Automated Insulin Delivery System pods after identifying a manufacturi...
FDA approves Novartis Cosentyx (secukinumab) for treating adolescents aged 12 and older with moderate to severe Hidradenitis Suppurativa.
FDA expands the approved use of GSKs Arexvy, a respiratory syncytial virus accine that now includes the in adults aged 18 to 49 who are at increased r...
Eli Lilly issues a public warning that its testing found that compounded tirzepatide with vitamin B12 can produce an unknown impurity from a chemical ...
BridgeBio says its investigational therapy BBP-418 showed consistent clinical benefit and a favorable safety profile in an interim analysis of the Pha...
FDA approves Johnson & Johnsons Tecnis PureSee Intraocular Lens, a new extended depth-of-focus lens for use in cataract surgery.
Two Axinn attorneys explain a new FDA draft guidance on new clinical investigation exclusivity and ways that some NDA and sNDA applicants may be able ...
Academic researchers call on FDA to continue to modernize its foreign drug inspection program and overcome differences in inspection intensity between...
