FDA seeks input on whether traditional statistical standards should be modified for rare disease clinical investigations, including when the agency mi...
FDAs approval of Outlook Therapeutics Lytenava shows that the agencys willingness to accept one adequate and well-controlled trial plus confirmatory e...
AstraZeneca and Daiichi Sankyo says that Enhertu cut the risk of disease progression or death by 37% compared with pembrolizumab (Mercks Keytruda) plu...
FDA extends by three months its review of an Exelixis NDA for zanzalintinib, in combination with atezolizumab, for treating patients with metastatic c...
Oncology Center of Excellence director Angelo de Claro says the center will build on initiatives established under longtime and former OCE chief Richa...
A Sheppard analysis warns that regulated industry should expect closer scrutiny of statements about FDA interactions and broaden their insider-trading...
A new report from the Association for Accessible Medicines calls for changes to FDA policies, patent law, pharmacy benefit manager practices and feder...
FDA grants Pharming Group expanded approval for Joenja (leniolisib) tablets for treating activated phosphoinositide 3-kinase delta syndrome in childre...
