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

The FDA has declined to approve Columvi, in combination with the chemo regimen GemOx, for the treatment of second-line DLBCL patients who are not eligible for autologous stem cell transplant, Roche ...

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

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

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

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

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

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...

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

Acadia Pharmaceuticals has received a complete response letter from the FDA stating that the administration cannot approve a supplemental new drug application for pimavanserin.The application ...

A paper published in the British Medical Journal, authored by FDA staff, compares content from FDA's complete response letter for a rejected drug, with the subsequent press release by drug developers.

FDA issues Complete Response Letter for sutimlimab, an investigational treatment for hemolysis in adults with cold agglutinin disease * Complete Response Letter refers to deficiencies from a pre ...