JD Supra2h
FDA Accepts U.S. Biologics License Application for AVT06, Alvotech and Teva’s Proposed Aflibercept Biosimilar
Alvotech and Teva Pharmaceuticals (“Teva”) announced that the U.S. Food and Drug Administration (FDA) has accepted for review ...
precisionmedicineonline3h
BMS Seeking FDA Approval for Opdivo-Yervoy in Frontline MSI-High, dMMR Advanced Colorectal Cancer
The firm submitted data from a Phase III study showing the combination improved outcomes compared to Opdivo and chemo alone.
Targeted Oncology5h
FDA Accepts sBLA for Nivolumab/Ipilimumab Combo in dMMR/MSI-H CRC
Nivolumab plus ipilimumab is being reviewed by the FDA as a first-line treatment for advanced colorectal cancer, with a ...
Contract Pharma6h
FDA Accepts Bristol Myers Squibb’s sBLA for Opdivo Plus Yervoy
The application was based on results from the three-arm Phase 3 CheckMate -8HW study.
FDA accepts Bristol Myers’ sBLA for Opdivo plus Yervoy
Squibb announced that the U.S. FDA has accepted the supplemental biologics license application for Opdivo plus Yervoy as a ...
JD Supra4d
Personal Jurisdiction Considerations for International Biosimilars Companies
The Federal Circuit recently issued decisions in a pair of appeals that provide guidance about when international filers of abbreviated ...
ophthalmologytimes6d
Alvotech and Teva Pharmaceuticals announce FDA accepts Biologics License Application for AVT06
Alvotech and Teva Pharmaceuticals announced the US Food and Drug Administration (FDA) has accepted for review a Biologics ...
Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept)
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 ...