The Pew Charitable Trusts lays out reasons why Congress should revise the system to update over-the-counter product monographs.
FDAs Oncologic Drugs Advisory Committee votes not to recommend approval of a Daiichi-Sankyo NDA for quizartinib, indicated for treating adults with re...
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide product-specific recommendatio...
FDA approves a W. L. Gore PMA for the Gore Tag Conformable Thoracic Stent Graft with Active Control System, an endovascular aortic repair device.
FDA approves a Genentech supplemental NDA for Venclexta (venetoclax) in combination with the companys Gazyva (obinutuzumab) for treating people with p...
A class action suit seeks damages and other penalties against Gilead and three other drug companies for restraining competition over important HIV/AID...
FDA updates Web pages related to Essure and Bayers required postmarket surveillance study.
Janssen raises issues from an FDA draft guidance on quality considerations for continuous manufacturing for further clarification and explanation.