The FDA issued a complete response letter to Genentech indicating it cannot approve the company’s biologic license ...

The FDA determined the data from STARGLO did not provide sufficient evidence to support approving glofitamab-gxbm (Columvi) in combination with gemcitabine and oxaliplatin to treat relapsed/refractory ...

There’s no “magic formula,” an attorney and former Labor Department official told HR Dive, but there are some best practices ...

The FDA has declined to approve Columvi, in combination with the chemo regimen GemOx, for the treatment of second-line DLBCL ...

The Wall Street Journal published a birthday note Donald Trump once wrote to Jeffrey Epstein, describing the financier as a ...

The FDA published their complete response letters to drug and biological product applications as part of an effort for more transparency.