The Department of Justice officially appeals Texas federal judge Matthew J. Kacsmaryks 4/7 controversial court order to undo FDAs 2020 approval of mif...
Merck and Eisai say they are discontinuing the Phase 3 LEAP-003 trial evaluating Keytruda plus Lenvima for first-line treatment of adults with unresec...
Horizon Therapeutics says it plans to discuss with FDA positive and statistically significant topline results from a Phase 4 clinical trial evaluating...
FDA grants Sumitomo Pharma Oncology an Orphan Drug Designation for TP-1287, an investigational oral CDK9 inhibitor for treating Ewing sarcoma.
Philips recalls (Class1) certain reworked DreamStation breathing devices due to some devices being assigned incorrect or duplicate serial numbers.
Federal Register notice: FDA seeks comments on an information collection extension entitled Imports and Electronic Import Entries (OMB Control Number ...
Federal Register notice: FDA adds quinacrine hydrochloride to its list of bulk drug substances (active pharmaceutical ingredients for which there is a...
Janssen Biotech and Pharmacyclics decide to voluntarily withdraw two accelerated approval indications for Imbruvica (ibrutinib) treating patients wit...
