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Asthma Drug Xolair Wins FDA Approval as First Treatment for Multiple Food Allergies

XTalks

The approval is indicated for reducing Type 1 allergic reactions, known as immediate reactions mediated by immunoglobulin E (IgE), in certain adults and children one year of age or older after accidental exposure to one or more foods. According to Genentech’s news release about the approval, based on 2024 estimates, 3.4

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This week in drug discovery (26 Feb – 1 March) 

Drug Discovery World

The first therapy was approved for allergic reactions to food, a drug for scleroderma secured Fast Track Designation, and the CHMP recommended an extension to the use of Carvykti in melanoma, but there was also bad news for Minerva Biosciences and Oncopeptides.

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FDA Approvals: Therapies for Lupus, MS, Cancer and a Genomic Alteration in Pigs

The Pharma Data

An Fc-engineered monoclonal antibody targeting the HER2 oncoprotein, MARGENZA offers hope for patients who have received two or more prior anti-HER2 regimens, with at least one being for metastatic disease. The FDA approval of Klisyri is a significant milestone for Athenex. Athenex, Inc.

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Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age

Pfizer

FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. Today’s approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age.

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GSK announces FDA approval for Nucala (mepolizumab) for use in adults with chronic rhinosinusitis with nasal polyps

The Pharma Data

First IL-5 therapy approved as an add-on treatment in the US for adults with chronic rhinosinusitis with nasal polyps to target eosinophilic inflammation Fourth indication for mepolizumab in the US for eosinophil-driven diseases. For over 50 years, GSK has led the way in developing medicines that advance the management of asthma and COPD.

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Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Adapted Bivalent Vaccine Candidate

Pfizer

Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 Tell your vaccination provider about all of the vaccine recipient’s medical conditions, including if the vaccine recipient: has any allergies. has a fever.

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

The Pharma Data

Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection across all approved U.S. Xolair is the only approved antibody designed to target and block immunoglobulin E (IgE). indications. Pulmozyme ® ?(dornase?alfa)