Managed Healthcare Executive

2025 FDA added indications to dermatologic medications

Libtayo's approval for high-risk cutaneous squamous cell carcinoma offers a new immunotherapy option, targeting PD-1 ...
Seeking Alpha

Dupixent® (dupilumab) Pivotal Trial Met All Primary and Secondary Endpoints, Reducing Signs and Symptoms of Allergic Fungal Rhinosinusitis (AFRS); sBLA Accepted for FDA ...

Phase 3 data to be presented at ACAAI demonstrate Dupixent significantly reduced key nasal signs and symptoms including sinus opacification, nasal congestion and nasal polyps in patients aged 6 years ...
Nasdaq

Dupixent® (dupilumab) Approved in the U.S. as the First-ever Biologic Medicine for Patients with COPD

Dupixent is indicated for the approximately 300,000 adults in the U.S. with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype Following recent ...
Nasdaq

Dupixent® (dupilumab) Approved in China as the First-ever Biologic Medicine for Patients with Chronic Obstructive Pulmonary Disease (COPD)

Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based on two landmark Phase 3 trials showing Dupixent significantly reduced exacerbations, improved ...
Seeking Alpha

Dupixent® (dupilumab) Approved as the First-ever Biologic Medicine in Japan for Patients with Chronic Obstructive Pulmonary Disease (COPD)

Following recent approvals in the EU, China and the U.S., this approval was based on pivotal Phase 3 results in adults with elevated eosinophils Approval marks the first new treatment approach for ...