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
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Glass Lewis Announces Multi-Perspective Framework
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
Biocon Launches Aflibercept Biosimilar in the United States
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
Deadline Approaching: OIG Seeks Input on Anti-Kickback Safe Harbors for Clinical Trial Participant Remuneration
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,
FDA Approves Moderna’s mFLUSIVA (mRNA-1010) Seasonal Influenza Vaccine
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
Public Company Advisory News Roundup: SEC Announces Formation of Specialized Unit Within Division of Enforcement to Combat Accounting and Financial Reporting Fraud
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
NYSE Seeks to Extend Internal Audit Transition Period to Five Years
On August 13, 2026, the SEC filed notice of a new rule proposal by the New York Stock Exchange (NYSE or the Exchange) to extend the transition period for newly public companies to have in place an internal audit function
FDA Revises Draft Guidance on Substantial Evidence of Effectiveness to Clarify Confirmatory Evidence Requirements for a Single Clinical Investigation
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
Amneal Completes Acquisition of Kashiv
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
Division of Corporation Finance Provides Update on Shareholder Proposal Process
On August 14, 2026, the SEC’s Division of Corporation Finance announced that it would discontinue responding to Rule 14a-8 no-action requests entirely, including those submitted under Rule 14a-8(i)(1), unless and until the Division announces otherwise. The Division also indicates that