FDA cites Bausch + Lomb for GMP deficiencies following a 3/12-20 inspection of the company's sterile drug manufacturing facility in Tampa, FL.
Amgen files new scientific data and analyses in its bid to prevent FDA withdrawal of Tavneos (avacopan), arguing that the treatment continues to demonstrate a favorable benefit-risk profile for patients with severe active ANCA-associated vasculitis.
FDA cites Bausch + Lomb for GMP deficiencies following a 3/12-20 inspection of the company's sterile drug manufacturing facility in Tampa, FL.
Amgen files new scientific data and analyses in its bid to prevent FDA withdrawal of Tavneos (avacopan), arguing that the treatment continues to demonstrate a favorable benefit-risk profile for patients with severe active ANCA-associated vasculitis.
FDA issues a Complete Response Letter to Apiject Systems Corp., declining to approve the company's NDA for a glycopyrrolate solution drug-device combination product.
FDA issues an early alert warning about a potentially high-risk issue involving certain lots of Boston Scientific's ENROUTE Transcarotid Neuroprotection System and ENROUTE Transcarotid Neuroprotection System Plus, following reports that the arterial sheath tip can separate during use.
