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

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.

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.

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 ...

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 ...