GSK secures FDA approval for Exdensur, the first twice-yearly biologic for treating severe asthma with an eosinophilic phenotype.

Depemokimab has been approved by the MHRA as the first and only biologic with twice-yearly dosing to treat asthma and severe ...

The U.S. health regulator has approved GSK's add-on treatment for severe asthma, offering a less frequently dosed option, but ...

With a fresh endorsement from the FDA, the last of five major drug approvals has fallen into place for GSK in 2025. | Tuesday ...

Regulators in the UK and US are the first to approve GSK's Exdensur, a long-acting, twice-yearly IL-5 inhibitor for severe ...

GSK plc announced the marketing authorisation of Exdensur (depemokimab) by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). In the UK, Exdensur is now approved in two indications: ...

GSK's asthma drug Exdensur, the first biologic for twice-yearly dosing, gains FDA approval for severe asthma treatment.

Exploration of key clinical trial data and real-world evidence on dupilumab in asthma and COPD presented at the ERS and CHEST ...

The MHRA has approved depemokimab as an add-on treatment for severe asthma and chronic rhinosinusitis with nasal polyps.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved pharma major GSK’s Exdensur (depemokimab), the first twice-yearly biological medicine for use as an add-on treatment for ...

GSK gets CHMP backing for Nucala in COPD and depemokimab in asthma, setting up possible Europe approvals in 2026 for IL-5 therapies.

As with any medicine, the MHRA will keep the safety and effectiveness of depemokimab under close review. The Medicines and Healthcare products ...