CDER says 45% of drug Warning Letters issued in fiscal year 2023 cited GMP requirement violations.
Federal Register notice: FDA makes available a final guidance entitled Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lin...
FDA grants Darmiyan a de novo marketing authorization for its clinical test BrainSee for assessing Alzheimers dementia risk.
Fresenius Kabi recalls its Ivenix Large Volume Pump because some units have mechanical issues with the fluid valve pins in the devices internal housin...
FDA approves Mercks Keytruda (pembrolizumab) with chemoradiotherapy (CRT) for treating patients with FIGO 2014 Stage III-IVA cervical cancer.
Three Democrat U.S. Reps. introduce the Pediatric Cancer Drug Supply Act of 2024, legislation that is intended to ensure there is an adequate supply o...
The Government Accountability Office says its testing of prenatal dietary supplements found that many had more or less nutrients than listed on the la...
FDA accepts for review a Shorla Oncology NDA for SH-105 for treating breast and ovarian cancer.
