FDA awards HelixBind a breakthrough device designation for its RaPID/BSI, a direct-from-blood platform for identifying and characterizing bloodstream ...
FDA issues Tricida a complete response letter on its NDA for veverimer, a non-absorbed, orally-administered polymer designed to treat metabolic acidos...
Valencia Technologies files a PMA for its eCoin Peripheral Neurostimulator System for use in treating overactive bladder.
Federal Register notice: FDA corrects a notice that appeared in the 7/7 Federal Register that discussed version 1.7 of the Clinical Data Interchange S...
CBER director Peter Marks says he would resign if the Trump Administration interfered in an approval decision to speed up access to a premature Covid-...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Dompe Farmaceuticis Oxervate (cenegermin-bkbj)....
Federal Register notice: FDA announces an 8/28 virtual public meeting entitled Public Meeting on CDER Standard Core Sets: Clinical Outcome Assessments...