FDA accepts for filing a Sandoz BLA for a biosimilar version of Amgens denosumab (Prolia and Xgeva), which includes all indications for the reference ...
FDA places a clinical hold on 4D Molecular Therapeutics 4D-310 drug therapy being studied for treating Fabry Disease Cardiomyopathy after the company ...
Federal Register notice: FDA makes available an annual report entitled Report on the Performance of Drug and Biologics Firms in Conducting Postmarketi...
CDRHs Accreditation Scheme For Conformity Assessment pilot program transitions to a permanent program based on review efficiencies it has demonstrate...
An FDA criminal case involving a Mays Landing, NJ, man who marketed a toxic chemical as a weight-loss drug online has led to a guilty plea on an obstr...
Medical device manufacturer Joint Active Systems (Effingham, IL) agrees to pay $500,000 under a Justice Department settlement over False Claims Act vi...
FDA approves a Gilead Sciences supplemental BLA for Trodelvy for treating certain adult patients breast cancer who have received endocrine-based thera...
Senator Jeanne Shaheen (D-NH) leads a group of Senators in sending a letter to Danco Laboratories, a manufacturer of mifepristone, urging it to submit...
