FDA sends Ascelia Pharma a Complete Response Letter regarding its NDA for Orviglance, a contrast agent for liver imaging.
Two Sheppard attorneys discuss an HHS Inspector General advisory opinion backing a drug companys arrangement with a third-party laboratory for free an...
During a CBS News interview, former CDC chief medical officer Debra Houry says she left the agency after concluding she could no longer defend its sci...
FDA briefing materials show that agency reviewers have found limited evidence supporting the safety and effectiveness of seven peptide substances that...
FDA warns Chinas BMC Medical that it is marketing adulterated and misbranded ventilators in the U.S. without an approved PMA in place for the devices....
FDA approves an expanded age indication for Vertex Pharmaceuticals sickle cell drug Casgevy.
FDA warns 3B Medical about multiple violations in its work manufacturing a software device used with ventilator systems imported from China.
FDA warns AseptiKits it is manufacturing and marketing adulterated and misbranded PALA Your Tears medical devices.
