Getty ImagesRegeneron Pharmaceuticals shared positive results from the company’s Phase III trial of a candidate drug for children with homozygous familial hypercholesterolemia (HoFH), a rare, life-threatening condition characterized by elevated circulating levels of low-density lipoprotein cholesterol (LDL-C) and accelerated, premature atherosclerotic cardiovascular disease (ACVD.
The U.S. Food and Drug Administration approved Sanofi’s Dupixent (dupilumab) 300 mg weekly to treat patients with eosinophilic esophagitis (EoE) aged 12 years and older, weighing at least 40 kg. With this approval, Dupixent is the first and only medicine specifically indicated to treat EoE in the United States.
Despite the loss of the company’s COVID-19 antibody REGEN-COV earlier in 2022, Regeneron posted a positive first quarter driven primarily by sales of Dupixent and Eylea.
Regeneron is acquiring Checkmate Pharmaceuticals and entered a clinical trial collaboration with SpringWorks Therapeutics to evaluate REGN5458 in multiple myeloma in combination with nirogacestat.
The U.S. Food and Drug Administration extended by three months the regulator agency’s review of Regeneron Pharmaceuticals Inc.’s application for full approval of the COVID-19 antibody therapy combination of casirivimab and imdevimab, the U.S. drugmaker said on April 14.
The U.S. Food and Drug Administration extended by three months the regulatory agency’s review of the Biologics License Application (BLA) for Regeneron Pharmaceuticals Inc.’s REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals.
Approval based on Phase 3 data showing Dupixent significantly reduced severe asthma attacks and also improved lung function and health-related quality of life for children Data reinforce well-established safety profile […]
The 71st annual American College of Cardiology’s Scientific Session saw several wins – and some “mehs” led by some of biopharma’s largest companies, according to BioSpace.
The U.S. Food and Drug Administration accepted for Priority Review the supplemental Biologics License Application for Dupixent (dupilumab) 300 mg weekly to treat adult and pediatric patients aged 12 years and older with eosinophilic esophagitis (EoE), a chronic and progressive type 2 inflammatory disease that damages the esophagus and impairs the ability to swallow.
BioNTech announced an expansion of a collaboration with Regeneron Pharmaceuticals to continue advancing mRNA technology and develop the FixVac candidate BNT116 in combination with Regeneron and Sanofi’s shared pharmaceutical product Libtayo (cemiplimab) for non-small cell lung cancer.