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Novartis Announces FDA Approval of Xolair for Nasal Polyps americanpharmaceuticalreview
December 22, 2020
Novartis announced the US Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the add-on maintenance treatment of nasal polyps in adult patients 18 years of age ...
Roche's Xolair gets US nod for nasal polyps treatment pharmatimes
December 03, 2020
Roche’s asthma med Xolair has scored approval from the US Food and Drug Administration (FDA) for the treatment of nasal polyps in adults.
FDA accepts application for self-administered Xolair use pharmatimes
August 14, 2020
The US Food and Drug Administration (FDA) has accepted Roche’s application for a new self-administration option for Xolair (omalizumab) across all approved US indications.
European Commission approves Novartis’ Xolair® (omalizumab) europeanpharmaceuticalreview
August 10, 2020
Novartis’ Xolair (omalizumab) has been approved by the European Commission as an add-on therapy with intranasal corticosteroids to treat severe chronic rhinosinusitis with nasal polyps.
EU approves new indication for Novartis’ Xolair pharmatimes
August 07, 2020
The European Commission has approved a new indication for Novartis’ Xolair (omalizumab) as an add-on therapy for the treatment of adults with sever chronic rhinosinusitis with nasal polyps (CRSwNP).
Novartis Receives Positive CHMP Opinion for New Xolair Indication americanpharmaceuticalreview
July 09, 2020
Novartis announced the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Xolair® (omalizumab) as an add-on therapy with intranasal corticosteroids (INC) ...
FDA agrees to review Novartis’ sBLA of Xolair to treat nasal polyps pharmaceutical-technology
December 16, 2019
The US Food and Drug Administration (FDA) has agreed to review a supplemental biologics license application (sBLA) submitted by Novartis to seek approval for Xolair (omalizumab) to treat nasal polyps.
Novartis receives European Commission approval for self-administration of Xolair® across all indications en-cphi.cn
December 14, 2018
Novartis today announced that the European Commission (EC) has approved Xolair® (omalizumab) prefilled syringe (PFS) for self-administration, allowing patients with severe allergic asthma (SAA) and chronic spontaneous urticaria (CSU) to administer their o
Novartis Receives EC Approval for Self-Administration of Xolair across all Indications americanpharmaceuticalreview
December 14, 2018
Novartis announced that the European Commission (EC) has approved Xolair (omalizumab) prefilled syringe (PFS) for self-administration.....
EC approves self-administration of Novartis’ Xolair pharmaceutical-technology
December 14, 2018
The European Commission (EC) has approved the prefilled syringe (PFS) of Novartis’ Xolair (omalizumab) medication for self-administration by patients with ......

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