On July 29, 2026, the FDA announced that it had licensed EZPLAZ FDP, the first freeze-dried (lyophilized) plasma product to be licensed in the United States. The license was issued to Vascular Solutions LLC, a subsidiary of Teleflex Incorporated.
EZPLAZ FDP is considered a biologic and is derived from a single unit of
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FDA Approves Orca Bio’s TREGZI for Allogeneic Hematopoietic Transplants
By Alice Yoon
On June 30, 2026, Orca Bio announced that the U.S. Food and Drug Administration (“FDA”) approved TREGZI for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host-free survival, in the treatment of adults with hematological malignancies.
TREGZI is manufactured individually for each…
FDA Approves Lupin’s Ranibizumab Biosimilar
On June 5, Lupin announced that the U.S. Food and Drug Administration (“FDA”) approved RANLUSPEC, a ranibizumab biosimilar to Genentech’s LUCENTIS®. RANLUSPEC, which received European Marketing Authorization earlier this year, is indicated for the treatment of neovascular (wet) age-related macular degeneration and other retinal vascular disorders. It is the only interchangeable biosimilar ranibizumab approved…
AbbVie Regulatory Submission and Deal News
AbbVie Submits Regulatory Application to FDA for Subcutaneous SKYRIZI
On April 27, 2026, AbbVie announced that it has submitted a regulatory application to the FDA seeking approval for SKYRIZI (risankizumab-rzaa) for subcutaneous induction for the treatment of adult patients with moderately to severely active Crohn’s disease. AbbVie states that its application is supported by positive data…
Year in Review: Big Deals of 2025
As we head into what is anticipated to be a strong year for biopharma dealmaking, we look back at some of the biggest deals in 2025 that focus on biologics and biosimilars.
Antibody Therapy Deals
Novartis acquires Avidity Biosciences
On October 26, 2025, Novartis AG and Avidity Biosciences, Inc. announced that they had entered into…
FDA to Phase Out Animal Testing for Monoclonal Antibodies and Other Drugs
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced it will be phasing out the current requirements for animal testing in the development of monoclonal antibody therapies and other drugs, replacing them “with more effective, human-relevant methods.” According to the FDA, the “animal testing requirement will be reduced, refined, or potentially replaced…