All News
Filter News
Found 622 articles
-
Dupixent® (dupilumab) Phase 3 Results Show Sustained Efficacy for Up to One Year in Children 1 to 11 Years of Age with Eosinophilic Esophagitis (EoE)
10/22/2023
Regeneron Pharmaceuticals, Inc. and Sanofi announced that positive results from a Phase 3 trial evaluating the investigational use of Dupixent® showed consistent efficacy and safety for up to one year in children aged 1 to 11 years with eosinophilic esophagitis.
-
Press Release: Dupixent® (dupilumab) Phase 3 Results show sustained efficacy for up to one year in children 1 to 11 years of age with eosinophilic esophagitis (EoE)
10/22/2023
Positive results from a Phase 3 trial demonstrated the efficacy and safety profile of Dupixent® for up to one year in children aged 1 to 11 years with eosinophilic esophagitis was consistent.
-
Libtayo® (cemiplimab) Neoadjuvant Treatment Demonstrates Encouraging Event-Free Survival in Patients with Resectable Cutaneous Squamous Cell Carcinoma (CSCC)
10/21/2023
Regeneron Pharmaceuticals, Inc. announced the first presentation of key secondary endpoints for an investigational regimen of PD-1 inhibitor Libtayo® as a neoadjuvant monotherapy in stage II to IV resectable cutaneous squamous cell carcinoma.
-
Regeneron and Sanofi Provide Update on Dupixent® (dupilumab) sBLA for Chronic Spontaneous Urticaria
10/20/2023
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in chronic spontaneous urticaria (CSU).
-
The FDA is gearing up for six decisions in the next two weeks, two of which involve highly anticipated medicines for rare diseases.
-
Regeneron to Showcase Progress from Innovative Oncology Portfolio in Several Difficult-to-Treat Cancers at ESMO
10/15/2023
Regeneron Pharmaceuticals, Inc. announced the latest clinical data in early- and late-stage cancers from its oncology pipeline will be presented at the European Society for Medical Oncology Congress 2023 from October 20 to 24 in Madrid, Spain.
-
Dupixent® (dupilumab) sBLA for Treatment of Eosinophilic Esophagitis (EoE) in Children Aged 1 to 11 Accepted for FDA Priority Review
9/26/2023
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application for Dupixent® to treat children aged 1 to 11 years with eosinophilic esophagitis.
-
Press Release: Dupixent® (dupilumab) sBLA for treatment of eosinophilic esophagitis in children aged 1 to 11 accepted for FDA Priority Review
9/26/2023
The U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application for Dupixent® to treat children aged 1 to 11 years with eosinophilic esophagitis.
-
Madrigal Pharmaceuticals Appoints Bill Sibold as Chief Executive Officer
9/11/2023
Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that Bill Sibold has succeeded Paul Friedman, M.D., as Chief Executive Officer (CEO) and joined Madrigal’s Board of Directors.
-
Press Release: Sanofi announces changes to its Executive Committee
8/31/2023
Houman, Madeleine and Emmanuel will report to Sanofi's CEO, Paul Hudson, and will be based in Paris, France.
-
Veopoz™ (pozelimab-bbfg) Receives FDA Approval as the First Treatment for Children and Adults with CHAPLE Disease
8/18/2023
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has approved Veopoz™ (pozelimab-bbfg) for the treatment of adult and pediatric patients 1 year of age and older with CHAPLE disease, also known as CD55-deficient protein-losing enteropathy.
-
Late-stage data from two studies showed Novartis’ BTK inhibitor remibrutinib improves symptoms of chronic spontaneous urticaria. The company will file for regulatory approval in 2024.
-
During Regeneron’s second-quarter earnings call Thursday, the company said that the regulator could make its decision on 8-mg Eylea in the third quarter—much earlier than market expectations.
-
Regeneron Reports Second Quarter 2023 Financial and Operating Results
8/3/2023
Regeneron Pharmaceuticals, Inc. announced financial results for the second quarter of 2023 and provided a business update.
-
Biosion Announces Phase II Study Start for Anti-TSLP mAb BSI-045B in Atopic Dermatitis (ADAMANT)
7/31/2023
Biosion USA, Inc., a global clinical-stage R&D biotechnology company, announced the phase 2 study initiation for the evaluation of BSI-045B, an anti-TLSP mAb, in the treatment of atopic dermatitis .
-
Press Release: Solid Q2 performance and strong pipeline momentum, Full-year 2023 business EPS guidance raised
7/28/2023
Vaccines up 9.1% due to strong PPH vaccines sales in Rest of World region and COVID vaccine supply in Europe.
-
Vaxxinity Appoints Peter Powchik, M.D., to Executive Vice President, Global Scientific Director
7/27/2023
Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the development of a new class of medicines, announced that Peter Powchik, M.D., will join Vaxxinity’s leadership team as Executive Vice President, Global Scientific Director starting October 1, 2023.
-
Pfizer’s Litfulo Poised to Follow Similar Trajectory as Eli Lilly/Incyte’s Olumiant for the Treatment of Severe Alopecia Areata
7/11/2023
In June 2022, Eli Lilly and Incyte’s Olumiant became the first and only approved advanced systemic treatment for adults with severe alopecia areata.
-
Banking on its lead antibody APG777 for atopic dermatitis, Apogee Therapeutics is filing an initial public offering for an as-yet-undisclosed value.
-
See inside for the top 20 biopharma companies with the most significant gaps in pay between their chief executives and median employees.