Genentech Announces FDA Approval of Xolair (omalizumab) for Adults with Nasal Polyps
South San Francisco, CA -- December 1, 2020 -- 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 company’s supplemental Biologics License... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 1, 2020 Category: Drugs & Pharmacology Source Type: news
FDA approves Xolair ® (omalizumab) for adults with nasal polyps
Basel, 01 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. 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 and older with inadequate response to nasal corticosteroids.1 Nasal polyps can lead to a loss of smell and nasal congestion, and frequently co-occur with other respiratory conditions, such as allergies and asthma. With this approval, Xolair is now the first biologic for the treatment ...
Source: Roche Investor Update - December 1, 2020 Category: Pharmaceuticals Source Type: news
FDA approves Xolair ® (omalizumab) for adults with nasal polyps
Basel, 01 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. 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 and older with inadequate response to nasal corticosteroids.1 Nasal polyps can lead to a loss of smell and nasal congestion, and frequently co-occur with other respiratory conditions, such as allergies and asthma. With this approval, Xolair is now the first biologic for the treatment ...
Source: Roche Media News - December 1, 2020 Category: Pharmaceuticals Source Type: news
Novartis announces FDA approval of Xolair(R) (omalizumab) for adults with nasal polyps
Xolair is the first biologic for the treatment of nasal polyps that targets and blocks immunoglobulin E (IgE), a key driver of inflammation
Xolair is now FDA-approved across three diseases and in two formulations, continuing to build on the medicine's 1... Biopharmaceuticals, FDA Novartis, Xolair, omalizumab, nasal polyps (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 1, 2020 Category: Pharmaceuticals Source Type: news
Use of omalizumab in fungal allergic asthma
Conference abstracts (Source: The Aspergillus Website - updates)
Source: The Aspergillus Website - updates - September 2, 2020 Category: Respiratory Medicine Authors: MeganB Source Type: news
Successful treatment of allergic bronchopulmonary aspergillosis with benralizumab after no response to omalizumab
Conference abstracts (Source: The Aspergillus Website - updates)
Source: The Aspergillus Website - updates - August 22, 2020 Category: Respiratory Medicine Authors: MeganB Source Type: news
Effects of omalizumab in allergic bronchopulmonary aspergillosis in 10 asthmatic patients
Conference abstracts (Source: The Aspergillus Website - updates)
Source: The Aspergillus Website - updates - August 22, 2020 Category: Respiratory Medicine Authors: MeganB Source Type: news
Allergic bronchopulmonary aspergillosis (ABPA) and omalizumab treatment
Conference abstracts (Source: The Aspergillus Website - updates)
Source: The Aspergillus Website - updates - August 20, 2020 Category: Respiratory Medicine Authors: MeganB Source Type: news
FDA accepts application for Xolair (omalizumab) prefilled syringe for self-administration across all indications
Basel, 13 August 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today 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) across all approved US 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. In the US, Xolair is currently approved for administration by a healthcare provider in a healthcare setting, and is the only approved...
Source: Roche Investor Update - August 13, 2020 Category: Pharmaceuticals Source Type: news
Omalizumab Relieves Aspirin-Exacerbated Respiratory Disease Omalizumab Relieves Aspirin-Exacerbated Respiratory Disease
Omalizumab reduces aspirin hypersensitivity and lowers leukotriene E4 (LTE4) levels in patients with aspirin-exacerbated respiratory disease (AERD), researchers in Japan report.Reuters Health Information (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - April 7, 2020 Category: Allergy & Immunology Tags: Pulmonary Medicine News Source Type: news
FDA grants Breakthrough Therapy Designation for Roche ’s Esbriet (pirfenidone) in unclassifiable interstitial lung disease
Basel, 3 March 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to Esbriet ® (pirfenidone) for adults with unclassifiable interstitial lung disease (uILD). The designation was granted based on data from a Phase II trial, which studied the efficacy and safety of Esbriet in uILD[1]. The study represented the first randomised controlled trial to exclusively enroll patients with progressive fibrosing uILD.“Today’s milestone for Esbriet builds on our continued commitment to improving the standard of care for people ...
Source: Roche Investor Update - March 3, 2020 Category: Pharmaceuticals Source Type: news
FDA accepts supplemental biologics license application for Xolair (omalizumab) for the treatment of nasal polyps
Roche announced today that the U.S. Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids. (Source: Roche Investor Update)
Source: Roche Investor Update - December 11, 2019 Category: Pharmaceuticals Source Type: news
Omalizumab Reduces Atopic Dermatitis Severity, Improves QOL in Kids Omalizumab Reduces Atopic Dermatitis Severity, Improves QOL in Kids
Omalizumab reduces the severity of atopic dermatitis (AD) in children, though it ' s not clear the improvement is clinically significant, according to a new randomized controlled trial.Reuters Health Information (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - November 28, 2019 Category: Allergy & Immunology Tags: Dermatology News Source Type: news
omalizumab (Xolair)
Title: omalizumab (Xolair)Category: MedicationsCreated: 5/27/2004 12:00:00 AMLast Editorial Review: 11/15/2019 12:00:00 AM (Source: MedicineNet Asthma General)
Source: MedicineNet Asthma General - November 15, 2019 Category: Respiratory Medicine Source Type: news
Ligelizumab May Improve Response in Chronic Urticaria Ligelizumab May Improve Response in Chronic Urticaria
Early trial results suggest the investigational humanized anti-IgE monoclonal antibody ligelizumab binds to IgE with greater affinity than FDA-approved omalizumab for refractory chronic spontaneous urticaria.Medscape Medical News (Source: Medscape Allergy Headlines)
Source: Medscape Allergy Headlines - October 3, 2019 Category: Allergy & Immunology Tags: Allergy & Clinical Immunology News Source Type: news
