FDA warns Par USA/Endo USA about CGMP violations in its manufacturing of finished drugs.
FDA warns Chinas Xiamen Kang Zhongyuan Biotechnology Co. about producing drugs in insanitary conditions and making misleading or deceptive statements ...
Two pharmacy professors say FDA needs to solicit expert and client input on its new Adverse Event Monitoring System dashboard and use the input to res...
FDA accepts a Roche supplemental BLA that seeks to expand use of Gazyva to treat Systemic Lupus Erythematosus.
FDA commissioner Marty Makary tells Fox Business that the agency will deploy its new national priority voucher program to significantly shorten drug r...
FDA approves Mercks Idvynso, a once-daily, single-tablet regimen for adults with HIV-1 who are already virologically suppressed.
Outlook Therapeutics completes a formal dispute resolution meeting with FDA as part of the companys push to revive its approval prospects for ONS-5010...
FDA outlines expanded efforts to reduce animal testing in drug development after reporting significant first-year progress under its roadmap to modern...
