Federal Register notice: FDA announces a 5/18 Vaccines and Related Biological Products Advisory Committee meeting to discuss a Pfizer BLA for Abrysvo ...
Federal Register notice: FDA announces a 6/9 Peripheral and Central Nervous System Drugs Advisory Committee to review an Eisai confirmatory study of A...
Federal Register notice: FDA announces a 5/12 Advisory Committee meeting to review a Sarepta Therapeutics BLA for a Duchenne muscular dystrophy drug.
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.
