FDA warns Wintac Limited about CGMP violations in its production of finished drugs at a facility in Bangalore, India.
FDA commissioner Stephen Hahn walks back his enthusiastic interpretation of data that supported the agencys recent decision to grant an emergency use ...
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.
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...
FDA issues a priority review voucher to Genentech for gaining approval of a rare pediatric disease product application Evrysdi (risdiplam).