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...
Neumora Therapeutics discontinues development of its lead depression candidate navacaprant after two Phase 3 studies failed to meet their primary and ...
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FDA posts a draft guidance to assist NDA sponsors in properly submitting patent information for listing in the agency's Orange Book.
