FDA posts a safety alert about Philips Respironics recalling certain bi-level positive airway pressure machines that may contain a plastic contaminate...
Erytech Pharma says it is no longer planning to submit a BLA for Graspa in hypersensitive acute lymphoblastic leukemia following FDA feedback that req...
New Phase 3 data on AstraZeneca's Farxiga (dapagliflozin) demonstrate a mortality benefit compared to placebo in patients with heart failure.
Intera Oncology recalls its Intera 3000 Hepatic Artery Infusion Pump due to complaints the device was delivering medications faster than expected.
Federal Register notice: FDA makes available a final guidance for industry entitled E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval...
Federal Register notice: FDA makes available a draft guidance entitled E11A Pediatric Extrapolation.
Federal Register notice: FDA makes available a draft guidance entitled M12 Drug Interaction Studies.
Federal Register notice: FDA sends to OMB an information collection revision entitled Review Transparency and Communication for New Molecular Entity N...
