FDA reauthorizes the emergency use of a LabCorp Covid-19 home collection test kit.
FDA says Kimera Labs should ensure its unapproved exosome products comply with all applicable laws and regulations.
BakerHostetler attorneys say drug companies need to be particularly sensitive to potential Covid-19 issues in CGMP compliance.
A new study shows that the Trump-touted malaria drug hydroxychloroquine does not reduce the risk of mechanical ventilation in patients hospitalized wi...
Medical school and hospital researchers say the quality of clinical evidence used to support drug approvals by FDA has changed in the last 30 years, s...
FDA approves an AbbVie supplemental NDA for Imbruvica (ibrutinib) in combination with rituximab for the first-line treatment of patients with chronic ...
FDA releases its latest batch of Warning Letters that includes one medical product company Tenderneeds Fertility.
FDA publishes a final guidance with a standardized method for device establishments to communicate and submit nonbinding requests for feedback on thei...