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
Goodwin Procter Blogs
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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…
Shareholder Proposals and ESG at a Crossroads: What Boards Should Know After the 2026 Proxy Season
The Weinberg Center’s fifth annual “ESG in the Boardroom” program, titled “Shareholder Proposals at the Crossroads: Boards, ESG, and the Future of SEC Rule 14a-8,” held April 28 in Wilmington, Delaware, brought together directors, jurists, advisors, and regulators to examine a governance environment in which boards are operating with less regulatory certainty and more direct…
SEC Chairman Atkins on AI: Strategy, Governance, and the Discipline of Principles
On March 4, 2026, SEC Chairman Paul S. Atkins delivered remarks at the Financial Stability Oversight Council’s Artificial Intelligence Innovation Series Roundtable on Strategy and Governance Principles, outlining how the Commission is approaching artificial intelligence as both a regulatory tool and a market development. In his remarks, Chairman Atkins addressed the implications of AI for…
Quick Takes from SRI 2026
At this year’s SRI, a few themes popped up in panels across a range of topics: disclosure trends; governance priorities; and frequently discussed interpretive questions.
IPO Comment Letter Timing: Still Long, but Improving
Initial comment letters for IPOs are still currently taking longer than the 30-day target reflective of both filing volume and working down…
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…
SEC Announces Creation of Task Force on Artificial Intelligence
On August 1, 2025, the Securities and Exchange Commission (SEC) announced the launch of a task force on artificial intelligence (AI) that will spearhead the agency’s efforts to enhance innovation and efficiency in its operations through the responsible use of AI. Valerie Szczepanik, who has been named the SEC’s Chief AI Officer, is leading the
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ISS Launches Annual Global Benchmark Policy Survey
By David Lynn
On July 24, 2025, Institutional Shareholder Services (ISS) announced the launch of its Annual Global Benchmark Policy Survey. In its announcement, ISS notes:
This year’s survey begins with core governance topics, including shareholder rights in relation to multi-class capital structures, considerations with regard to shareholder proposals, and board governance, with a focus on director overboarding.…