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

FDA accepts Pfizer’s hemophilia B (PFE) gene therapy application.

Zacks Investment Research

Pfizer PFE announced that its applications for approval in the United States and the European Union (EU) for the treatment of hemophilia B gene therapy fidanacogene elaparvovec have been accepted for review. While a final decision from the FDA is expected in the second half of 2024, a decision from the European Medicines Agency (EMA) … Read more

FDA accepts Pfizer’s hemophilia B (PFE) gene therapy application.

Zacks Investment Research

Pfizer PFE announced that its applications for approval in the United States and the European Union (EU) for the treatment of hemophilia B gene therapy fidanacogene elaparvovec have been accepted for review. While a final decision from the FDA is expected in the second half of 2024, a decision from the European Medicines Agency (EMA) … 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

Muscular Dystrophy Association Celebrates FDA Approval of Sarepta Therapeutics’ ELEVIDYS for Treatment of Duchenne Muscular Dystrophy | Muscular Dystrophy Association

Image of a DNA strand with the words, Breaking News, New FDA Drug Approval for Duchenne Muscular Dystrophy (DMD).  The first gene therapy for DMD.

Muscular Dystrophy Association Celebrates FDA Approval of Sarepta Therapeutics’ ELEVIDYS for Treatment of Duchenne Muscular Dystrophy The FDA approval of the first gene therapy for Duchenne muscular dystrophy (DMD) by Sarepta Therapeutics is groundbreaking and designed to target the underlying cause of the disease. The Muscular Dystrophy Association (MDA) has been around since the inception … Read more