For children 12 years of age and older, XOLAIR prefilled syringe may be self-injected under adult supervision. For children 6 to 11 years of age, ...

The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xolair ® (omalizumab; Genentech and Novartis) prefilled syringe for self-injection ...

During the first period, study participants (N=619) were randomly assigned to receive omalizumab-igec 300mg, Xolair 300mg, omalizumab-igec 150mg, or Xolair 150mg for 12 weeks.

The FDA has accepted for filing the sBLA for a new self-administration option of omalizumab (Xolair; Novartis) prefilled syringe across all indications.

If approved, Xolair prefilled syringe would become available for either self-administration by select patients or administration by their caregivers. A decision on approval is anticipated by Q1 2021.

Before starting self-injection with Xolair prefilled syringe, the patient must have no prior history of anaphylaxis and be closely observed by a healthcare provider for at least three injections ...

If approved, Xolair prefilled syringe would become available for either self-administration by select patients or administration by their caregivers. A decision on approval is anticipated by Q1 2021.

Novartis and Roche have worked to expand Xolair's reach with new formulations and approvals in new diseases. In 2014, the drug won the FDA's blessing to treat chronic hives—specifically, chronic ...

Sept 28 (Reuters) - Roche Holding AG: Exclusive news, data and analytics for financial market professionals Learn more about Refinitiv ...

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration has approved the company’ s supplemental Biologics License Application for Xolair ® prefilled ...

– Xolair for self-injection offers healthcare providers and appropriate patients another administration option for more flexibility in managing their treatment – Genentech, a member of the ...