Alvotech and Teva Pharmaceuticals (“Teva”) announced that the U.S. Food and Drug Administration (FDA) has accepted for review ...

The firm submitted data from a Phase III study showing the combination improved outcomes compared to Opdivo and chemo alone.

The vaccine, created by Zoetis, is intended for use in chickens.

Nivolumab plus ipilimumab is being reviewed by the FDA as a first-line treatment for advanced colorectal cancer, with a ...

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for dupilumab to treat adults with bullous pemphigoid.

The application was based on results from the three-arm Phase 3 CheckMate -8HW study.

Squibb announced that the U.S. FDA has accepted the supplemental biologics license application for Opdivo plus Yervoy as a ...

The Federal Circuit recently issued decisions in a pair of appeals that provide guidance about when international filers of abbreviated ...

Alvotech and Teva Pharmaceuticals announced the US Food and Drug Administration (FDA) has accepted for review a Biologics ...

In addition to AVT06, which is a biosimilar candidate for Eylea ® (aflibercept) 2 mg, Alvotech is currently also developing AVT29, a biosimilar candidate for Eylea ® HD (aflibercept) 8 mg. Teva also ...

has accepted for review the Biologics License Application (BLA) of Lerodalcibep to reduce low-density lipoprotein cholesterol (LDL-C) for the treatment of patients with atherosclerotic ...