This section highlights FDA-related milestones and regulatory updates for drugs developed by GSK (GSK).
Over the past two years, GSK has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Nucala and Benlysta. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Nucala (mepolizumab) FDA Regulatory Timeline and Events
Nucala (mepolizumab) is a drug developed by GSK for the following indication: Adults with chronic rhinosinusitis with nasal polyps.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Nucala (mepolizumab)
- Announced Date:
- February 6, 2026
- Indication:
- Adults with chronic rhinosinusitis with nasal polyps
Announcement
GSK plc announced the European Commission has approved Nucala (mepolizumab), a monoclonal antibody targeting interleukin-5 (IL-5), in adults as an add-on maintenance treatment for uncontrolled COPD characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA).
Read Announcement- Drug:
- Nucala (mepolizumab)
- Announced Date:
- May 22, 2025
- Indication:
- Adults with chronic rhinosinusitis with nasal polyps
Announcement
GSK plc announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab)as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilicphenotype.
AI Summary
GSK plc announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype. This approval marks the first time a biologic targeting IL-5 has been approved for COPD patients whose blood eosinophil count starts at 150 cells/µL. Clinical evidence from the MATINEE and METREX phase III trials showed that Nucala reduced the rate of moderate to severe exacerbations, which can lead to hospitalizations or emergency room visits.
With nearly 70% of COPD patients in the US experiencing persistently high eosinophil levels despite inhaled triple therapy, this approval offers a promising new option for managing symptoms and reducing exacerbations. Nucala’s use is expected to improve care for many patients vulnerable to the severe impacts of this chronic respiratory disease.
Read Announcement- Drug:
- Nucala (mepolizumab)
- Announced Date:
- September 6, 2024
- Indication:
- Adults with chronic rhinosinusitis with nasal polyps
Announcement
GSK plc announced positive headline results of MATINEE, the phase III clinical trial evaluating Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5) in adults with chronic obstructive pulmonary disease (COPD).
Read Announcement
Benlysta (Belimumab) FDA Regulatory Events
Benlysta (Belimumab) is a drug developed by GSK for the following indication: Lupus Nephritis (LN).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Benlysta (Belimumab)
- Announced Date:
- June 24, 2025
- Indication:
- Lupus Nephritis (LN)
Announcement
GSK plc announced that the US Food and Drug Administration (FDA) has approved a 200 mg/mL autoinjector of Benlysta (belimumab), a B-lymphocyte stimulator (BlyS)-specific inhibiting monoclonal antibody, for subcutaneous injection in patients five years of age and older with active lupus nephritis (LN) who are receiving standard therapy.
AI Summary
The US FDA recently approved a 200 mg/mL autoinjector of Benlysta (belimumab) for subcutaneous injections in patients aged five years and older with active lupus nephritis who are receiving standard therapy. Developed by GSK plc, this autoinjector offers a new at-home treatment option by allowing the medicine to be self-administered with ease. Benlysta is a monoclonal antibody that targets BLyS, a protein involved in the survival of B cells, which helps control the overactive immune response seen in lupus nephritis.
This approval expands treatment options by giving pediatric patients and their caregivers a more convenient alternative to intravenous infusions. It is an important development in managing a severe complication of lupus that can lead to kidney damage. The new device supports better continuity of care and offers improved flexibility for those battling the condition.
Read Announcement
