FDA says there is an implementation delay for isotretinoin iPLEDGE Risk Evaluation and Mitigation Strategy modifications.
FDA warns Chelmsford, ME-based Zoll Medical about Quality System and Medical Device Reporting violations in its manufacturing of several medical devic...
A citizen petition urges FDA to impose an immediate moratorium on the use of gadolinium-based contrast agents in MRI scans.
FDA authorizes Colorado's prescription drug importation program, marking another step forward for state-led efforts to lower drug costs through import...
FDA and the UK's Medicines and Healthcare products Regulatory Agency announce a new liaison program designed to strengthen collaboration between the t...
Eli Lilly reports positive Phase 3 results for its BTK inhibitor Jaypirca (pirtobrutinib) in combination with venetoclax and rituximab.
Significant operational hurdles remain before FDA's Plausible Mechanism Framework can be broadly implemented, according to a commentary published by S...
FDA increases scrutiny of telehealth companies marketing compounded drugs, warning that some firms are making false or misleading claims about compoun...
