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...
FDA accepts for a priority review a Genentech BLA for faricimab for treating wet, or neovascular, age-related macular degeneration and diabetic macula...
Researchers say many reporters to the FDA MAUDE medical device database misclassify deaths in other categories.
FDA says Emergent BioSolutions can resume producing J&J Covid-19 vaccine at its Bayview manufacturing facility.