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
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
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,
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
On August 26, 2026, the SEC submitted a rule proposal titled “Executive Compensation Disclosure Reform” to the White House’s Office of Information and Regulatory Affairs (OIRA). Those SEC rulemaking initiatives that are under review by OIRA are listed on a
In October 2025, Glass Lewis announced plans to shift from singularly-focused research and vote recommendations anchored by a global voting policy toward providing multiple perspectives reflecting the viewpoints of clients.
On August 26, 2026, Glass, Lewis & Co. sent a
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
On June 24, 2026, the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) issued a Request for Information (“RFI”) seeking stakeholder input on payments received by individuals in connection with clinical trial participation. Specifically,
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
The latest issue of the Goodwin Public Company Advisory News Roundup has been posted, covering the period from August 1, 2026 – August 14, 2026. The Roundup highlights the latest developments in SEC and stock exchange regulatory activity, corporate governance
