Category: North America

March 19, 2022 Off

U.S. Food and Drug Administration Approves First LAG-3-Blocking Antibody Combination, Opdualag™ (nivolumab and relatlimab-rmbw), as Treatment for Patients with Unresectable or Metastatic Melanoma

By Author

Opdualag, a first-in-class, fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.

Relatlimab is the third immune checkpoint inhibitor from Bristol Myers Squibb, adding to the Company’s growing and differentiated oncology portfolio.

March 18, 2022 Off

Moderna asks FDA’s approval for the 4th Dose Covid-19 Vaccine

By Dino Mustafić

Moderna has submitted a request to the U.S. Food and Drug Administration (FDA) for an amendment to the emergency use authorization (EUA) to allow for a fourth dose of its COVID-19 vaccine (mRNA-1273) in adults 18 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines.

March 16, 2022 Off

Toxys Opens US Office and Production Facility to Accelerate Growth

By Dino Mustafić

Toxys BV, a Dutch biotech company that offers a broad spectrum of innovative in vitro toxicology solutions for the safety assessment of novel medicines, (agro)chemicals, cosmetics, and food ingredients, has announced the opening of a sales office in New York (NY) and a production facility in Gaithersburg (DE) to accelerate the company’s growth.