Federal Register notice: FDA determines that Bausch Health Americas Efudex (fluorouracil) topical solution, 5%, was not withdrawn from sale for reason...
Federal Register notice: FDA makes available a draft guidance entitled Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization C...
A bipartisan group of four senators asks HHS to pursue policies to allow Americans to import some drugs from Canada.
Washington Legal Foundations asks the 1st Circuit Court of Appeals to reverse the conviction of two former medical device executives for distributing ...
FDA approves an Allergan label expansion for Botox to include eight new muscles for treating upper limb spasticity in adults.
FDA posts upcoming changes to the clozapine REMS (risk evaluation and mitigation strategy).
FDA releases the transcript from a 5/6 CBER virtual workshop on patient engagement and regenerative medicine.
FDA clears a Volpara Health 510(k) for the latest version of its key science algorithm, Volpara Imaging Software (VIS 3.2), a breast density assessmen...