FDA warns Canadas Sante Manufacturing about CGMP issues found in an agency review of requested records detailing the firms manufacturing of over-the-c...
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...
Neumora Therapeutics discontinues development of its lead depression candidate navacaprant after two Phase 3 studies failed to meet their primary and ...
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...
