FDA cautions consumers not to use products marketed as mole or skin tag removers.
FDA approves a Foundation Medicine PMA for its FoundationOne CDx to be used as a companion diagnostic for the two approved indications for Genentechs ...
Four additional stakeholders raise concerns about the FDA quality metrics proposal.
FDA releases the FDA-483 with five observations issued following a 2021 inspection at Largo, FL-based BPI Labs.
Some 18 members of Congress ask FDA 19 questions about Covid-19 vaccine safety in children under age 5.
University of Kentucky researchers say FDA should consider moving to an alternate approach to monitoring drug quality rather than relying on current g...
FDA delays making a decision on Novavaxs Covid-19 vaccine emergency use authorization request after the company submitted last minute manufacturing da...
A bipartisan group of six senators calls on the U.S. Patent and Trademark Office to change its policies and procedures to eliminate so-called patent t...