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.

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

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 ...

CINCINNATI--(BUSINESS WIRE)--LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company today announced the U.S. Food and Drug Administration (FDA) has accepted for review the ...