AbbVie asks FDA to approve a new indication for Rinvoq to treat patients with active ankylosing spondylitis.
FDA clears a Gyroscope Therapeutics 510(k) for the Orbit Subretinal Delivery System, indicated for microinjection into the subretinal space at the bac...
FDA releases its latest batch of Warning Letters that includes Banco Vida, Custom Nutraceuticals and Wintac Limited.
FDA warns Custom Nutraceuticals about CGMP violations that adulterate its dietary supplements.
FDA approves Recordatis Cystadrops for reducing cystine crystal deposits in the cornea of the eye.
The Justice Department says Dusa will pay $20.75 million to resolve a whistleblowers charges that it induced doctors to file false claims for its Levu...
A new FDA study of 252 difficult-to-make prescription drugs finds that U.S.-marketed products consistently meet quality standards even when manufactur...
FDA says it is delaying collection of new drug manufacturing data to help it track potential drug shortages until an electronic data submission portal...