Business Wire

Genentech’s HEMLIBRA (emicizumab-kxwh) Continued to Substantially Reduce Bleeds in People with Hemophilia A with Inhibitors

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new data from the ongoing HEMLIBRA ® (emicizumab-kxwh) clinical ...
FiercePharma

Roche nabs blockbuster FDA approval for Hemlibra, big label expansion for Gazyva

Call it a big day for Roche at the FDA, as the drug giant picked up two critical approvals on Thursday, first for hemophilia A drug Hemlibra and then with a label expansion for Gazyva. Hemlibra won ...
Business Wire

New Data From Phase IIIb Study Reinforces Safety Profile of Genentech’s Hemlibra (emicizumab-kxwh) in People With Hemophilia A

– Second interim analysis of the STASEY study, including data from 193 patients, consistent with results from Phase III HAVEN studies, with no new safety signals identified – – STASEY is the largest ...
pharmaphorum

Roche reveals haemophilia drug data ahead of label expansion decision

Roche has revealed new trial data that make the case for use of its haemophilia A drug Hemlibra in an expanded patient group, ahead of a decision by the FDA in the autumn. Hemlibra (emicizumab) is ...
Monthly Prescribing Reference

Hemlibra Approved to Treat Hemophilia A With Inhibitors

Genentech announced that the Food and Drug Administration (FDA) has approved Hemlibra (emicizumab-kxwh) injection for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in ...