Former FDA official Grail Sipes says questions are emerging about the long-term impact of the Commissioners National Priority Voucher program, warning...
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Two Axinn attorneys explain a new FDA draft guidance on new clinical investigation exclusivity and ways that some NDA and sNDA applicants may be able ...
