FDA releases its latest batch of Warning Letters that includes one medical product company Taiwan Biotech Company.
The DC federal court orders FDA to grant orphan drug exclusivity to Eagle Pharmaceuticals Bendeka.
FDA approves Mercks Keytruda (pembrolizumab), an anti-PD-1 therapy for treating patients with recurrent or metastatic cervical cancer with disease pro...
FDA issues a draft guidance on its Humanitarian Device Exemption (HDE) Program that clarifies the current review practices for the regulatory pathway....
Federal Register notice: FDA determines that Mutamycin (mitomycin) injectable, 5mg/vial and 20mg/vial, was not withdrawn for reasons of safety or effe...
Federal Register notice: FDA announces the renewal of its Pharmacy Compounding Advisory Committee for an additional two years.
Federal Register notice: FDA publishes a listing of recent OMB-approved information collections.
Federal Register notice: FDA announces the renewal of its Drug Safety and Risk Management Advisory Committee for an additional two years.