FDA grants Reach Neuro a breakthrough designation for its Avantis platform, which the company says uses small electrical impulses delivered to the spi...
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...
