FDA extends by three months its review of a Bayer NDA for elinzanetant, a neurokinin 1 and neurokinin 3 receptor antagonist for treating menopause-rel...
FDA and American Society of Clinical Oncology researchers urge drug makers to abandon outdated drug dosing strategies that are potentially putting can...
Edwards Lifesciences recalls (Class 1) its OptiSite Arterial Perfusion Cannula and Peripheral Femoral Arterial Cannula after receiving reports in whic...
FDA issues an alert based on related to its ongoing investigation into the root causes of benzene contamination, calling on drug makers to evaluate th...
Ethicon Endo-Surgery recalls (Class 1 device correction) its Echelon Flex Powered Vascular Stapler to correct the products inadvertent lockout during ...
Medline Industries recalls (Class 1 device correction) certain lots of its Craniotomy Kits containing recalled Codman Disposable Perforators 14mm, whi...
FDA will give priority review to a Sprout sNDA to expand the indication for Addyi to treat low sexual desire in post-menopausal women.
FDA reportedly is requiring additional safety data from Sarepta Therapeutics before the agency considers supporting use of the companys Duchenne muscu...
