In a recent interview with PharmaShots, Ted Omachi, Global Development Leader for Xolair, and Senior Medical Director of Product Development for Immunology, Genentech shared his views on the approval of […]readmore
Tags : Xolair
The US FDA has accepted the sBLA for a new self-administration option for Xolair (omalizumab) across all approved US indications. In an interview with PharmaShots, Ted Omachi the Global Development […]readmore
Shots: The US FDA has accepted the sBLA for a new self-administration option for Xolair across all approved indications in the US. The company anticipates the approval of the therapy […]readmore
Shots: The sBLA submission is based on P-III POLYP 1 & 2 studies assessing Xolair (SC) vs PBO in 138 & 127 patients with CRSwNP with inadequate response to intranasal […]readmore
Shots: The P-III POLYP 1 & POLYP 2 studies results involve assessing of Xolair (SC, q2w/q4w) vs PBO in 138 & 127 patients with CRSwNP with inadequate response to intranasal […]readmore
Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012. The Breakthrough Designation is granted to […]readmore
Shots: The approval is based on trial results assessing Xolair IV (q2w or q4w) in 1M patients with SAA and CSU for 13 years The study demonstrated in reduction of severe exacerbations, corticosteroid […]readmore
Shots: The BT designation is based on seven clinical studies evaluating safety and efficacy for allergens including peanut, milk, egg and others The BT designation for Xolair (omalizumab) is to […]readmore