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

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

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

The FDA's request stems from observations made during recent inspections of Ultragenyx's manufacturing facilities.

The U.S. Food and Drug Administration released more than 200 of its so-called complete response letters from its archive on ...

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...

For instance, "the backlog of FOIAs ... is enormous," he said. Califf said the FDA has far greater opportunities for improved ...

The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...

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

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 ...

Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees ...

The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. | ...