On August 19, 2026, the U.S. Food and Drug Administration approved Regeneron’s PASATRU™ (garetosmab-grts) for the treatment of adults with fibrodysplasia ossificans progressiva (FOP), an ultra-rare genetic disorder characterized by progressive heterotopic ossification (HO), the formation of bone in muscles, tendons, ligaments, and other connective tissues. According to Regeneron, PASATRU…
On August 20, 2026, the FDA published guidance intended to provide answers to frequently asked questions about the development of cellular and gene therapy (“CGT”) products to help facilitate the development of safe, effective, and high-quality CGT products. The FDA’s guidance is in response to the Prescription Drug Use Fee…
On August 26, 2026, Takeda Pharmaceuticals USA, Inc. and Takeda Pharmaceuticals International AG (collectively, “Takeda”) filed a BPCIA complaint in the U.S. District Court for the District of New Jersey against Polpharma Biologics S.A. (“Polpharma”), alleging that Polpharma’s vedolizumab biosimilar, PB016, will infringe six patents related to Takeda’s ENTYVIO (vedolizumab)….
On August 18, 2026, Biocon Ltd. (“Biocon”) announced that its U.S. subsidiary has received supplemental U.S. FDA approval for YESINTEK® (ustekinumab-kfce) in a single-dose prefilled autoinjector, 45 mg/0.5 mL and 90 mg/mL. YESINTEK® was originally approved by the FDA on November 29, 2024, in 45 mg/0.5 mL or 90 mg/mL…
On August 3, 2026, Biocon Limited announced the commercial launch of its biosimilar YESAFILI (aflibercept-jbvf) in the United States. YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor that is used to treat various ophthalmic conditions. YESAFILI references Regeneron’s EYLEA (aflibercept) 2 mg product. The FDA approved YESAFILI as an…
On August 5, 2026, Moderna announced that the FDA approved mFLUSIVA (mRNA-1010), a new seasonal influenza vaccine, for use in all adults 50 years of age and older. As we previously reported, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted that the benefits of Moderna’s mRNA-1010 outweigh its…
On August 10, 2026, Amneal Pharmaceuticals, Inc. completed its acquisition of Kashiv BioSciences, LLC. According to Amneal, the acquisition results in “a fully integrated global biosimilars leader with end-to-end capabilities across research, development, manufacturing and commercialization,” and “establishes one of the industry’s few fully integrated biosimilars platforms.” Amneal’s Co-Founder and…
On June 25, 2026, the U.S. Food and Drug Administration (FDA) announced the availability of revised draft guidance titled “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products.” The original draft guidance was issued in December 2019. When finalized, the revised draft guidance will replace the FDA’s 1998…
On August 1, 2026, Fresenius Kabi and Dr. Reddy’s Laboratories announced that the FDA had approved Dr. Reddy’s rituximab biosimilar, a biosimilar to Genentech’s RITUXAN® (rituximab). Rituximab is a monoclonal antibody that targets the CD20 antigen expressed on B lymphocytes and is used in the treatment of several B-cell malignancies,…
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…