Cyltezo Biosimilar launches today in the United States

Cyltezo Biosimilar launches today in the United States

Boehringer Ingelheim today announced that its biosimilar adalimumab (Humira; AbbVie) Cyltezo (adalimumab-adbm) is now commercially available in the United States.1 Cyltezo is the first and only adalimumab interchangeable biosimilar approved by the US Food and Drug Administration (FDA). Cyltezo was first approved by the FDA in 2017 and received interchangeability designation in 2021. As of … Read more

FDA approves first cell therapy to treat patients with type 1 diabetes

FDA approves first cell therapy to treat patients with type 1 diabetes

SILVER SPRING, Md., June 28, 2023 /PRNewswire/ — Today, the United States Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cell therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. the treatment of adults with type 1 diabetes who are unable to reach target glycated hemoglobin … Read more

Verona Pharma submits a new drug application to the US FDA for ensiphentrin for the maintenance treatment of COPD

Verona Farmaceutica srl

Verona Farmaceutica srl LONDON & RALEIGH, NC, June 27, 2023 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (Verona Pharma or the Company) announces the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the approval of ensifentrin for the maintenance treatment of patients with chronic obstructive pulmonary … Read more