Business Wire

FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved the ...
Pharmabiz

US FDA approves Roche’s Xolair prefilled syringe for self-injection across all indications

Roche announced that the US Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application (sBLA) for Xolair (omalizumab) prefilled syringe for self-injection ...
Pharmabiz

US FDA accepts Novartis’ sBLA for Xolair prefilled syringe for self-administration across ...

Novartis announced that the US Food and Drug Administration (FDA) accepted the company's supplemental Biologics License Application (sBLA) for a new self-administration option for Xolair (omalizumab) ...
Business Wire

Phase III Study Shows Xolair May Be More Effective With Fewer Side Effects Than Oral ...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new positive data from Stage 2 and Stage 3 of the National Institutes ...