Category: Regions

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
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.

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

Gamifant Approved in China for the Treatment of Primary HLH
March 18, 2022 Off

Gamifant Approved in China for the Treatment of Primary HLH

By Dino Mustafić

Sobi has announced that the National Medical Products Administration of China (NMPA) has approved Gamifant (emapalumab) for use in China. The indication is for treatment of adult and paediatric (newborn and older) patients with primary haemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance to conventional HLH therapy.