FDA warns Chinas Wuhu Chemistry about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
Olympus recalls its bronchoscope single-use guide sheath kits due to potential for the radiopaque tip of the sheath component to separate and fall off...
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 accepts for review a Regeneron Pharmaceuticals BLA resubmission for linvoseltamab for treating adult patients with relapsed/refractory multiple my...
