On July 9, 2026, Teva Pharmaceuticals International GmbH (“Teva”) and Polpharma Biologics International AG (“Polpharma Biologics”) announced a global licensing agreement under which Teva will obtain exclusive rights to commercialize Polpharma Biologics’ proposed biosimilar to Genentech’s OCREVUS (ocrelizumab), including both
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Harrow Re-Launches BYOOVIZ (ranibizumab-nuna) in the United States
On July 1, 2026, Harrow announced the commercial launch of BYOOVIZ (ranibizumab-nuna), an FDA-approved biosimilar referencing LUCENTIS (ranibizumab). BYOOVIZ was developed by Samsung Bioepis Co., Ltd. (“Samsung Bioepis”).
BYOOVIZ was originally launched in the United States by Biogen in 2022.
SEC Staff Issues New CFIs on Schedule 13D, Total Return Swaps and Proxy Rules
Securities Trading on the Newly-Launched Texas Stock Exchange
The Texas Stock Exchange (TXSE) commenced quoting and trading securities pursuant to unlisted trading privileges on July 6, 2026, and the new national securities exchange intends to commence trading of other securities on the exchange in the coming weeks. The
FDA Approves Orca Bio’s TREGZI for Allogeneic Hematopoietic Transplants
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
Celltrion and Teva’s TRUXIMA® Becomes First Interchangeable Rituximab Biosimilar in U.S.
On July 1, 2026, Celltrion announced that the FDA had granted interchangeability designation to TRUXIMA® (rituximab-abbs), Celltrion and Teva’s biosimilar to Genentech’s RITUXAN®. With this designation, TRUXIMA® became the first rituximab biosimilar to receive interchangeable status in the United States.
FDA Expands Indication for Vertex’s CASGEVY to Children Aged Two Years and Older
On July 1, 2026, Vertex Pharmaceuticals announced that the FDA approved an expanded indication for CASGEVY (exagamglogene autotemcel) to treat children aged two years and older with sickle cell disease (SCD) experiencing recurrent vaso-occlusive crises or who have transfusion-dependent beta
SEC Releases 2026 Regulatory Agenda
On July 7, 2026, SEC Chair Paul Atkins issued a statement on the Commission’s 2026 Regulatory Agenda. In the statement, Atkins said the SEC is focused on investor protection, capital formation, and market efficiency, and that the agenda is
FDA Advisory Committee Votes in Favor of Moderna Flu Vaccine Benefit-Risk Profile
On July 30, 2025, Moderna announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted that the benefits of Moderna’s investigational mRNA influenza vaccine, mRNA-1010 (proposed brand name mFlusiva), outweigh its risks for adults ages 50
FDA Approves Viridian’s LUMVOA for Thyroid Eye Disease
On June 26, 2026, Viridian Therapeutics announced that the U.S. Food and Drug Administration (“FDA”) approved LUMVOA (veligrotug-vvze) for the treatment of thyroid eye disease (“TED”), regardless of disease activity or duration. LUMVOA is Viridian’s first FDA-approved medicine and its