FierceBiotech

PRESS RELEASE: FDA approves Mircera: first renal anemia treatment in the US with monthly maintenance dosing

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 ...
Monthly Prescribing Reference

Mircera Approved to Treat Anemia in Pediatric Patients With CKD

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 ...
Healio

FDA approves Mircera for treatment of anemia in pediatric patients on hemodialysis

Please provide your email address to receive an email when new articles are posted on . The FDA approved Mircera for the treatment of pediatric patients 5 to 17 years of age on hemodialysis who are ...
PharmaTimes

FDA approves Roche’s anaemia drug Mircera

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 ...
Reuters

Roche says U.S. extends Mircera review period

ZURICH, Dec 15 (Reuters) - Swiss drugmaker Roche Holding AG said on Friday the U.S. Food and Drug Administration had extended the review period for its anaemia drug Mircera for patients with chronic ...
Medindia

FDA Approves MIRCERA(R): First Renal Anemia Treatment with Monthly Maintenance Dosing

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 ...