FDA grants fast track designation to a Zentalis investigative drug for uterine serous carcinoma.
The Alzheimers Association and other stakeholders are launching a national registry for Alzheimers diagnostic and treatment information.
Two Wiley Rein attorneys suggest ways companies could approach the new FDA section 510(j)(3) drug reporting requirement.
SterRx recalls 240 lots of various drug products within their expiry period due to equipment and process issues that could lead to a lack of sterility...
FDA clears an Avinger 510(k) for a new clinical indication for the Pantheris image-guided atherectomy system treating in-stent restenosis in the lowe...
Federal Register notice: FDA withdraws approval of 18 ANDAs from multiple applicants after they notified the agency that the drugs were no longer mark...
Public Citizen says FDA should disqualify from conducting clinical trials two doctors at the Hennepin County Medical Center and the centers institutio...
FDA grants fast track designation to AstraZenecas hyperkalemia drug Lokelma to reduce arrhythmia-related cardiovascular outcomes in patients on chroni...