Sanofi-Regeneron's Dupixent wins FDA's nod for 'smoker's lung'
WEB3 days ago · The U.S. Food and Drug Administration has approved Sanofi and Regeneron's blockbuster drug Dupixent for patients with a chronic lung disease, commonly known as "smoker's lung", the companies said ...
Blockbuster Dupixent wins FDA approval for COPD - STAT
WEB3 days ago · Sept. 27, 2024. West Coast Biotech & Life Sciences Reporter. Dupixent is already a blockbuster therapy for a range of immune-mediated diseases, but the Food and Drug Administration’s approval of ...
FDA greenlights Regeneron’s Dupixent for the treatment of COPD
WEB3 days ago · With an approval based on two pivotal Phase III studies, Dupixent is now the first-ever biologic indicated for treating COPD.
Dupixent® (dupilumab) Approved in the U.S. as the First-ever …
WEB3 days ago · 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 ...
Press Release: Dupixent approved in the US as the first-ever …
WEB3 days ago · Dupixent approved in the US as the first-ever biologic medicine for patients with COPD Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an ...
Sanofi blockbuster drug wins clearance in US for lung disease
WEB3 days ago · Sanofi’s Dupixent has been cleared for a chronic lung disorder in the US, in another milestone for the blockbuster drug after a similar decision by European regulators.
Update on FDA Priority Review of Dupixent® (dupilumab) for the ...
WEBMay 31, 2024 · Dupixent, which was invented using Regeneron’s proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the …
US FDA approves Sanofi-Regeneron's Dupixent for 'smoker's lung'
WEB(Reuters) -The U.S. Food and Drug Administration has approved Sanofi and Regeneron's blockbuster drug Dupixent for patients with a chronic lung disease, commonly known as "smoker's lung", the ...
FDA, after delay, clears Regeneron and Sanofi drug for COPD
WEB3 days ago · European regulators approved Dupixent for COPD in July, but Regeneron and Sanofi have had to wait longer in the U.S., where the FDA requested additional efficacy data from the two trials. Over that time, a potential new competitor has emerged in GSK’s Nucala, which the FDA rejected in 2018 but earlier this month succeeded in a Phase 3 trial.
Dupixent® late-breaking data from NOTUS confirmatory phase 3 …
WEBMay 20, 2024 · NOTUS results confirm landmark data from the phase 3 BOREAS study and show Dupixent significantly reduced exacerbations by 34% and improved lung function, compared to placebo, in uncontrolled chronic obstructive pulmonary disease (COPD) with evidence of type 2 inflammation. Data support the potential of …