FDA warns Thomas Advanced Medical about illegally marketing human cell and tissue products.
Federal Register notice: FDA withdraws approval of a Fosun Pharma ANDA for pemoline tablets after the company requested it be withdrawn.
FDA clears an Abbott 510(k) for its Alinity i TBI blood test for detecting traumatic brain injuries.
FDA announces a 3/30 workshop entitled Immune Globulin (IG) Hypersensitivity Reactions: Root Causes and Mitigation that is intended to address excessi...
Researchers call on drug companies to ensure that labels for drugs with accelerated approval indications contain approval pathway and surrogate marker...
FDA says it is working with additional manufacturers of hemodialysis and peritoneal dialysis systems to determine the potential risk of patient exposu...
FDA grants Neuromod Devices a de novo request to market Lenire, the first bimodal neuromodulation device for treating tinnitus.
Aclaris Therapeutics says a Phase 2 clinical study investigating the efficacy and safety of zunsemetinib in treating hidradenitis suppurativa did not ...
