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.
The Friends of Cancer Research suggests possible additions to an FDA draft guidance on optimizing the dosage of oncologic drugs.
FDA warns Rogers, AR-based Dunagin Pharmaceuticals, which does business as Massco Dental, about CGMP violations in its manufacturing of finished drugs...
FDA warns Torrance, CA-based Cosmetic Science Laboratories about CGMP and other violations in its production of finished drugs as a contract manufactu...
