Roche and Eli Lilly collaborate to develop Roches Elecsys Amyloid Plasma Panel, a blood test designed for making earlier diagnoses of Alzheimers disea...
The CBER FY 2022 biological product deviation reporting annual summary says there was a 3% increase in reports submitted over FY 2021.
A new University of Colorado Boulder study points to the need for FDA to work harder to follow and consider further regulating social media micro-infl...
FDA approves an expanded indication for Regeneron Pharmaceuticals Evkeeza (evinacumab-dgnb) as an adjunct to other lipid-lowering therapies to treat c...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Novo Nordisks Esperoct (antihemophilic factor (...
Federal Register notice: FDA amends certain medical device regulations to update mailing addresses and docket numbers.
FDA approves a Sandoz supplemental BLA for citrate-free Hyrimoz (adalimumab-adaz) injection, a biosimilar version of Abbvies Humira.
The International Council for Harmonization approves the S12 guidance on nonclinical biodistribution studies for gene therapy products.
