House Energy and Commerce Committee chairman Frank Pallone (D-NJ) introduces the Accelerated Approval Integrity Act that would revamp FDAs accelerated...
FDA approves Bristol Myers Squibbs Opdivo (nivolumab) 360 mg (injection for intravenous use) five days after submitting an NDA for adult patients with...
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...