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

The Pharma Data

Tonya Winders, CEO & President, Allergy and Asthma Network (AAN) and President of Global Allergy and Airways Patient Platform (GAAPP) commented: “Patients with chronic rhinosinusitis with nasal polyps experience unpleasant symptoms across a range of severities. It is not currently approved for use in COPD anywhere in the world.

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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. The Roche Group’s immunology medicines include: Actemra ® /RoActemra ® ?(tocilizumab) today announced that the U.S.

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FDA accepts Dupixent® (dupilumab) for Priority Review in patients aged 12 years and older with eosinophilic esophagitis

The Pharma Data

If approved, Dupixent would be the first medicine available in the U.S. The target action date for the FDA decision on this investigational use is August 3, 2022. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.

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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. Pfizer and BioNTech also filed these data with the European Medicines Agency (EMA) and other regulatory authorities around the world.

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FDA accepts Dupixent® (dupilumab) for review in children with moderate-to-severe asthma

The Pharma Data

Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Dupixent is approved in the U.S.

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FDA accepts Dupixent® (dupilumab) for Priority Review in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis

The Pharma Data

FDA a ccepts Dupixent ® (dupilumab) for Priority Review in c hildren a ged 6 m onths to 5 y ears with m oderate-to-severe a topic d ermatitis. If approved, Dupixent will be the first biologic medicine available in the U.S. The target action date for the FDA decision on this investigational use is June 9, 2022. In the U.S.,

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First Single-Shot Vaccine in Fight Against Global Pandemic

The Pharma Data

The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021. The Company will ship the vaccine using the same cold chain technologies it uses today to transport treatments for cancer, immunological disorders and other medicines. There is no FDA-approved vaccine to prevent COVID-19.