Allarity Therapeutics says it is no longer economically feasible to pursue its dovitinib as a monotherapy for some renal cancers and it is refocusing ...
FDA publishes a draft guidance on the electronic submission of expedited individual case safety reports from IND-exempt BA/BE studies through the adve...
Federal Register notice: FDA makes available a final guidance entitled Policy Regarding N-acetyl-L-cysteine.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Genentechs Rozlytrek tablets (entrectinib).
Federal Register notice: FDA permanently debars Duniel Tejeda from providing services in any capacity to a person that has an approved or pending drug...
The Senate Appropriations Committee posts its fiscal year 2023 proposed budget bill for FDA that increases the agencys spending by $229 million (7%), ...
An Amgen study says the FDA accelerated approval program is working well and should not be changed because there are some drug outliers in the program...
Jones Day attorneys update FDAs commitments for a regulatory framework to address artificial intelligence as a tool for advancing medical therapeutics...