AnaptysBio reports positive data from a Phase 2 study of rosnilimab for treating moderate-to-severe rheumatoid arthritis.
Max Mobility recalls its Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial for wheelchair use due to a faulty circuit board in its speed contro...
The Department of Justice has requested information from Inspire Medical as part of a civil probe into its marketing, promotion, and reimbursement pra...
FDA clarifies its enforcement discretion timeframes for compounded tirzepatide.
FDA approves a Genentech NDA for a new tablet formulation of Evrysdi (risdiplam) for treating people with spinal muscular atrophy.
FDA warns Mesquite, TX-based Strukmyer Medical about CGMP violations in manufacturing finished drugs and cosmetics.
FDA warns Chinas Chengdu Innovation Pharmaceutical Co. about CGMP deviations in manufacturing active pharmaceutical ingredients.
DC federal judge John Bates orders FDA and CDC to re-post Web pages and datasets they removed to comply with President Trumps executive order on gende...
