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.
Federal Register notice: FDA sends to OMB a new information collection entitled Generic Clearance for Data To Support Cross-Center Collaboration for S...
The Justice Department says Bioventus is paying over $3.6 million to resolve allegations of violating the False Claims Act through improperly completi...