FDA issues Fennec Pharmaceuticals a complete response letter on its NDA for Pedmark (sodium thiosulfate), for preventing ototoxicity associated with c...
FDA warns Taka USA about CGMP violations in its production of finished pharmaceuticals.
FDA says that over 200 SARS-CoV-2 tests have been approved through emergency use authorizations, with hundreds more in the pipeline.
FDA clears a Life Spine 510(k) for the Plateau-X Ti Lateral Lumbar Spacer System.
Rep. Raja Krishnamoorthi says science has demonstrated that adolescent vapers are at a higher risk of contracting Covid-19 and thus e-cigarettes shoul...
Becton, Dickinson recalls its ChloraPrep 3 mL applicator due to possible fungal contamination.
FDA medical reviewers ask the Oncologic Drugs Advisory Committee to discuss whether Mesoblast has demonstrated that its remestemcell-L is effective in...
Genentech says its etrolizumab failed to meet Phase 3 endpoints in patients with ulcerative colitis.