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...
Jazz Pharmaceuticals says its Phase 3 LAGOON study evaluating Zepzelca (lurbinectedin) in relapsed small cell lung cancer failed to meet its primary e...
FDA approves AstraZeneca's AKT inhibitor Truqap (capivasertib) in combination with abiraterone and prednisone for adults with PTEN-deficient metastati...
FDA posts a draft guidance to assist NDA sponsors in properly submitting patent information for listing in the agency's Orange Book.
