Business Wire

Nucala (mepolizumab) Gains FDA Approval for Two New Self-Administration Options

LONDON--(BUSINESS WIRE)--GlaxoSmithKline (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved two new methods for administering Nucala (mepolizumab), an ...
Business Wire

Nucala is the first biologic approved in the US for six to 11-year-old children with severe eosinophilic asthma

Nucala (100mg dose subcutaneous injection) was first approved in 2015 as an add-on maintenance treatment for patients with severe eosinophilic asthma aged 12 years and older. This approval (40mg dose ...
FiercePharma

GSK Announces Nucala® (mepolizumab), Now Available In The Us For Sub-Group Of Patients With Severe Asthma

RESEARCH TRIANGLE PARK, N.C., Dec. 2, 2015 /PRNewswire/ -- GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that Nucala® (mepolizumab), the first and only biologic add-on therapy for people 12 ...
Monthly Prescribing Reference

FDA Approves Nucala for Severe Asthma

The FDA has approved Nucala (mepolizumab; GlaxoSmithKline) for injection as add-on maintenance treatment of patients with severe asthma aged ≥12 years. The Food and Drug Administration (FDA) has ...
Wall Street Journal

FDA Approves GlaxoSmithKline’s Nucala as Add-on to Treat Severe Asthma

GlaxoSmithKline PLC’sGSK-1.57%decrease; red down pointing triangle Nucala therapy has been approved to treat patients with severe asthma attacks in combination with other drugs, the Food and Drug ...
Nasdaq

FDA Approves Nucala as the First and Only Biologic Treatment for Hypereosinophilic Syndrome (HES)

Third US indication for Nucala demonstrates GSK’s commitment to finding new ways to help patients with eosinophil-driven diseases Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: ...
Nasdaq

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

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 ...
RAPS

FDA Approvals Roundup: Nucala, Fetroja, Xeljanz

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). GlaxoSmithKline’s Nucala (mepolizumab injection) has been granted a new indication for the ...
WebMD

FDA OKs Nucala for Hard-to-Treat COPD

May 23, 2025 -- The FDA has approved the asthma drug Nucala for adults with chronic obstructive pulmonary disease (COPD). It is the second biologic therapy approved for the condition, following the ...
News Medical

Nucala Solution

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. Why am I being given NUCALA? NUCALA contains the active ingredient ...
FierceBiotech

GSK ANNOUNCES NUCALA® (mepolizumab), NOW AVAILABLE IN THE US FOR SUB-GROUP OF PATIENTS WITH SEVERE ASTHMA

A majority of the systemic reactions were experienced on the day of dosing. Injection site reactions (e.g., pain, erythema, swelling, itching, and burning sensation) occurred at a rate of 8% in ...