The catheters approved by the FDA include the Plato 17, a DMSO-compatible microcatheter, and the Socrates 38, an aspiration catheter specifically designed for treating ischemic strokes.
Myhibbin is reportedly the first FDA-approved liquid formulation of mycophenolate, a key immunosuppressant used to prevent organ rejection in transplant recipients.
Acceptance of the application was based on promising results from the Phase III CheckMate -67T study, which displayed noninferiority between the oral and intravenous formulations of Opdivo.
New formulation of Cyltezo aims to complement the existing low-concentration formulation and offer more treatment options for various chronic inflammatory diseases.