FDA approves an additional indication for GlaxoSmithKlines Benlysta to treat children with active lupus nephritis who are receiving standard therapy.
FDA warns Shrewsbury, NJ-based Bi-Coastal Pharma International about CGMP violations in its manufacturing of finished drugs.
FDA warns St. Louis, MO-based Jost Chemical Co. about CGMP deviations in its production of active pharmaceutical ingredients.
FDA places a clinical hold on an unidentified Immuron investigational drug being evaluated for treating campylobacter and enterotoxigenic escherichia ...
FDA clears an iRhythm Technologies 510(k) for its ZEUS (Zio ECG Utilization Software) System for the Zio Watch.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Alkermes Vumerity (diroximel fumarate), indicat...
Federal Register notice: FDA revokes the Emergency Use Authorization issued to Gilead Sciences for Veklury (remdesivir) for treating Covid-19 because ...
Avadel sues FDA over the agencys decision to require a patent statement for the companys Lumryz NDA.