Regeneron says it will respond to a recent FDA complete response letter on the companys BLA for a higher dose of Eylea (aflibercept) 8 mg to treat pat...
FDA warns Erlanger, KY-based RenatiLabs that it is illegally marketing human cell products that are manufactured with significant CGMP deviations.
Federal Register notice: FDA announces the publication of modifications the agency is making to its list of standards recognized for use in premarket ...
Federal Register notice: FDA seeks comments on an information collection revision entitled Premarket Notification for a New Dietary Ingredient21 CFR 1...
FDA warns Centaur Pharmaceuticals about CGMP issues in its manufacturing of drugs at its facility in Maharashtra, India.
FDA says the deadline for submissions for the next cycle of the Advancing Real-World Evidence program is 9/30.
FDA publishes a draft guidance with recommendations for single-entity and fixed-combination antiretroviral drugs to be distributed outside of the U.S....
FDA chief scientist Namandj Bumpus says the agency is looking to revamp its advisory committees to convene panels that will solicit input on broader s...
