FDA approves an Advanced Bionics PMA supplement to add an acoustic earhook for its the Nada CI Q90 sound processor that transforms the device into a c...
Journalism professor Charles Seife details ways in which he says FDA is withholding information about Sareptas Exondys 51 to protect the company.
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Wellstat Therapeutics Xuriden (uridine triaceta...
Merck KGaA and Pfizer report that the Phase 3 JAVELIN gastric cancer trial did not meet its primary endpoint of superior overall survival with aveluma...
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Relypsas Veltassa (patiromer sorbitex calcium),...
An FDA webinar explains the principles underlying two new final guidances on when to submit a new 510(k) for changes to a medical device or to softwar...
FDA releases the FDA-483 issued following an inspection at Northridge Hospital Dignity Health sterile drug products production facility.
The HHS Inspector General has withdrawn a favorable advisory opinion for the Caring Voice Coalition funded by drug companies to help Medicare patients...