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 ...

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 ...

Federal Reserve Chair Jerome Powell responded by letter Thursday to a senior Trump administration official who accused the ...

Online users shared a screenshot of the February 2025 letter, suggesting it contradicted a finding that Jeffrey Epstein ...

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

The FDA accepted Aldeyra's resubmitted NDA for reproxalap after previous rejections due to efficacy concerns, despite no ...

Sebas, I speak to you now directly. God has you as his target, you’ll have no peace, no joy, no rest, no satisfaction until you yield to Him! Do not be like the rich young ruler who when asked by ...

The FDA published a database containing more than 200 letters to pharmaceutical companies detailing why the agency initially refused to approve their products, The New York Times reported July 10. FDA ...

The firm said the agency cited chemistry, manufacturing, and controls issues in its complete response letter, but had no concerns about product quality.