The application was based on results from the three-arm Phase 3 CheckMate -8HW study.
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 ...
So far, five biosimilars that reference Eylea 2 mg have been approved by the FDA. Alvotech/Teva expect to regulatory approval ...
We expect investors to focus on the sales performance of ADMA Biologics’ ADMA portfolio of marketed products and other ...
The Federal Circuit recently issued decisions in a pair of appeals that provide guidance about when international filers of abbreviated Biologics License Applications (aBLAs) are subject to ...
Alvotech and Teva Pharmaceuticals have announced the FDA's acceptance of their Biologics License Application for AVT06, a proposed biosimilar to Eylea®, aimed at treating various eye disorders ...
Squibb announced that the U.S. FDA has accepted the supplemental biologics license application for Opdivo plus Yervoy as a ...
has accepted for review a Biologics License Application (BLA) for AVT06, Alvotech’s proposed biosimilar to Eylea ® (aflibercept), a biologic used to treat eye disorders, including diseases ...
Alvotech and Teva Pharmaceuticals announced that the U.S. FDA has accepted for review a Biologics License Application for AVT06, a proposed biosimilar to Eylea® (aflibercept), which treats eye ...