First biologic approved in the European Union for adults with severe chronic rhinosinusitis with nasal polyposis (CRSwNP) Dupixent now approved in the EU for three type 2 inflammatory diseases: severe ...

TARRYTOWN, N.Y. and PARIS, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved ...

Dupixent also met all secondary endpoints in both trials, including demonstrating a significant reduction in the need for systemic corticosteroids or surgery, and improvements in smell and chronic ...

The approval in adolescent patients was based on evidence from the phase 3 SINUS-24 and SINUS-52 trials. The Food and Drug Administration (FDA) has expanded the approval of Dupixent ® (dupilumab) to ...

The FDA approval is based on two pivotal trials (the 24-week SINUS-24 and 52-week SINUS-52) that are part of the Phase 3 LIBERTY clinical trial program. These trials evaluated Dupixent 300 mg every ...

Common side effects of Dupixent for atopic dermatitis (eczema) include injection site reactions like pain or swelling, eye-related side effects such as pink eye or dry eyes, and increased risk of cold ...

Approval in adults and children aged 6 years and older supported by Phase 3 trial demonstrating Dupixent significantly reduced nasal signs and symptoms, and systemic corticosteroid use or surgery ...

Patients receiving dupilumab showed clinical improvement in nasal congestion and smell, and were less likely to require systemic corticosteroids or additional sino-nasal surgery. The Food and Drug ...

Dupixent interacts with some medications like seizure drugs (phenytoin, carbamazepine), warfarin, and certain heart medications, potentially increasing side effects or reducing their effectiveness.

Paris and Tarrytown, N.Y. - October 16, 2018 - Two pivotal Phase 3 placebo-controlled trials evaluating Dupixent ® (dupilumab) in adults with inadequately-controlled chronic rhinosinusitis with nasal ...