Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Mircera (methoxy polyethylene glycol-epoetin beta) for the treatment of anaemia associated with chronic kidney ...
The approval was based on an open-label, multiple dose, multicenter, dose-finding study in 64 pediatric patients with CKD who were on hemodialysis and who had stable hemoglobin levels while previously ...
US regulators have given the green light to Roche's new anaemia drug Mircera, but no launch across the Atlantic is likely for some time as the Swiss firm is embroiled in a legal dispute it is losing ...
Roche’s hopes to get its new anaemia treatment Mircera onto the market have been hampered by US regulators who have only issued an approvable letter for the compound, amid fears about the safety of ...
NUTLEY, N.J., Nov. 14 Roche announced today that the U.S. Food and Drug Administration (FDA) has approved MIRCERA (methoxy polyethylene glycol-epoetin beta) for the treatment of anemia associated with ...