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 thalassemia (TDT). The approval makes CASGEVY the first CRISPR-based gene-editing…
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 to 64 and adults ages 65 and older. mRNA-1010 is…
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 first commercial product. TED is a rare autoimmune disease characterized…
On June 19, 2026, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, “Janssen”) filed a BPCIA Complaint in the U.S. District Court for the Eastern District of Virginia against Alvotech hf. and Alvotech USA Inc. (collectively, “Alvotech”) for patent infringement related to Alvotech’s proposed golimumab biosimilars (AVT05 SC and…
On June 12, 2026, Xbrane Biopharma AB (“Xbrane”) and JOINN Biologics US Inc. (“JOINN”) announced a strategic partnership to develop Xdarzane, Xbrane’s biosimilar candidate to DARZALEX (daratumumab), which is approved for the treatment of multiple myeloma. Big Molecule Watch has previously covered daratumumab biosimilar development, including Dr. Reddy’s 2025 license…
On June 10, 2026, Organon announced that the U.S. Food and Drug Administration (FDA) approved a supplemental biologics license application (sBLA) for TOFIDENCE ® (tocilizumab-bavi), an intravenous biosimilar to Genentech’s ACTEMRA® (tocilizumab). The approval expands TOFIDENCE’s indications to include: (1) adults and pediatric patients (2 years of age and older)…
On June 4, 2026, Teva Pharmaceutical Industries Ltd. (“Teva”) announced the launch of its aflibercept biosimilar, AHZANTIVE®, in Europe. According to Teva’s press release, the launch of AHZANTIVE® pre-filled syringes across European markets commenced in May 2026. The launch follows Teva’s semi-exclusive commercialization agreement with Klinge Biopharma GmbH and Formycon…
On June 8, Incyte announced that it has entered into a definitive agreement to acquire Vega Therapeutics, a wholly owned subsidiary of Star Therapeutics. The transaction would add VGA039, an investigational monoclonal antibody in Phase 3 development for von Willebrand disease, to Incyte’s hematology portfolio. Under the agreement, Incyte will…
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…
On June 8, Alvotech announced that the U.S. Food and Drug Administration (“FDA”) has accepted Alvotech’s Biologics License Application (“BLA”) for AVT16, a proposed interchangeable biosimilar to Takeda’s ENTYVIO (vedolizumab), for review. ENTYVIO is a humanized monoclonal antibody approved for the treatment of adults with moderately to several active ulcerative…