A CDC advisory committee recommends that the U.S. resume vaccinations with Johnson & Johnsons Covid-19 vaccine.
Federal Register notice: FDA updates the availability of guidance documents related to the Covid-19 public health emergency.
Federal Register notice: FDA determines that Hospiras sodium chloride 14.6% solution for injection (50 milliequivalent/20 milliliters) in plastic cont...
FDA grants a de novo marketing authorization for Neurolutions IpsiHand Upper Extremity Rehabilitation System for use in adult patients undergoing stro...
Cordis recalls (Class 1) its Precise PRO Rx Carotid System because of the potential for the distal tip to become separated from the lumen wire.
A Texas state senator introduces legislation to facilitate manufacturer sharing of information on off-label uses for drugs.
FDA and Ultragenyx reach an agreement on the design and endpoints for a Phase 3 study of the companys DTX301 ornithine transcarbamylase gene therapy p...
Federal Register notice: FDA announces a 6/9 public workshop entitled Model Informed Drug Development Approaches for Immunogenicity Assessments.