Shanghai Junshi Biosciences and Coherus Biosciences begin a rolling BLA submission for toripalimab for treating recurrent or metastatic nasopharyngeal...
The National Institutes of Health (NIH) halts a clinical trial evaluating Covid-19 convalescent plasma in treating emergency department patients who d...
Federal Register notice: FDA seeks comments on an information collection extension entitled Current Good Manufacturing Practice for Finished Pharmaceu...
FDA warns HealthQuilt about objectionable conditions in its role as a clinical trial investigator.
FDA unexpectedly sends FibroGen and partner AstraZenecas NDA for chronic kidney disease anemia drug roxidadustat to its Cardiovascular and Renal Drugs...
Politico details drug industry pressure on FDA to find a way to conduct facility inspections despite the pandemic.
Merck withdraws a Keytruda (pembrolizumab) indication for treating patients with metastatic small cell lung cancer with disease progression on or afte...
FDA approves labeling changes for ViiVs Triumeq and Dovato.