FDA warns ActiveHerb Technology about multiple violations in its manufacture and sale of unapproved and misbranded new drugs.
FDA clears a Misonix 510(k) for Nexus, an ultrasonic surgical platform.
The House Appropriations Committee marks up and passes the fiscal year 2020 Agriculture/FDA appropriations bill that would provide the agency with an ...
Boehringer Ingelheim expresses general support for an FDA final guidance on considerations in demonstrating interchangeability with a reference produc...
FDA releases its latest batch of Warning Letters that includes ActiveHerb Technology and Kingston Pharma.
Federal Register notice: FDA submits to OMB an information collection extension for Guidance for Industry on Establishing That a Tobacco Product Was C...
FDA accepts for review a Celgene and Acceleron BLA for luspatercept for treating certain patients with very low to intermediate-risk myelodysplastic s...
FDA approves a TransMedics Group PMA for expanded clinical indications of the Organ Care System Lung to be used for the preservation and ex-vivo asses...