FDA approves an Oticon Medical PMA for the companys Neuro System, a cochlear implant for treating individuals 18 years or older with bilateral severe-...
Retired FDA psychiatry products director Thomas Laughren joins Cybin as a clinical advisory board member.
FDA warns Fresh Nutrition it is selling misbranded and unapproved new human and animal drugs.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Daiichi Sankyos Turalio (pexidartinib).
FDA releases an FDA-483 with two observations from an inspection at Venus Concept.
New FDA-posted review documents provide more insight into how FDA reconciled using the accelerated approval pathway for Biogens Alzheimers drug Aduhel...
Two University of Connecticut professors say it will take a long time for FDA to recover from drug manufacturing inspections that couldnt be conducted...
The HHS Inspector General says the Center for Medicare and Medicaid Services should work with FDA and other partners to find the best way to address c...