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

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 patients who are not eligible for autologous stem cell transplant, Roche ...

FDA says the move boosts regulatory transparency, offering insights into common approval barriers in drug applications and reducing guesswork.

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

While the CRL derails a near-term clearance, one analyst described the rejection as more of “a speed bump to approval, rather ...

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

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

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

US FDA accepts for review Milestone Pharma’s response to CRL for Cardamyst nasal spray: Montreal Monday, July 14, 2025, 11:00 Hrs [IST] Milestone Pharmaceuticals Inc., a biophar ...

US FDA embraces radical transparency by publishing complete response letters: Maryland Monday, July 14, 2025, 14:00 Hrs [IST] The US Food and Drug Administration (FDA) published m ...