FDA grants Merit Medical Systems a breakthrough device designation for its Embosphere Microspheres for use in genicular artery embolization procedures...
FDA Review posts the Federal Register notices for the week ending 3/4/2022.
FDA Review posts product approval summaries for the week ending 3/5/2022.
FDA declines to grant Ocugen an emergency use authorization for Covaxin for active immunization to prevent Covid-19 in individuals aged two to 18 year...
Federal Register notice: FDA issues an order to debar Patrick Charles Bishop for a period of five years from importing or offering for import any drug...
Sanofi petitions FDA to mandate a labeling change to Seqirus influenza vaccine products Fluad and Fluad Quadrivalent to reflect that a confirmatory st...
A CDER online post updates the Centers efforts to support rare disease drug development, particularly through data sharing initiatives that are import...