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
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
On June 25, 2026, the U.S. Food and Drug Administration (FDA) announced the availability of revised draft guidance titled “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products.” The original draft guidance was issued in December 2019.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
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
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
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
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.
On July 29, 2026, Genentech, Inc. (“Genentech”) and Hoffmann-La Roche Inc. filed a complaint in the U.S. District Court for the District of New Jersey against Biocon Biologics Inc. (“Biocon”) and related entities, alleging infringement of 28 patents relating to
On July 30, 2026, Meitheal Pharmaceuticals, Inc. (“Meitheal”) announced that the U.S. Food and Drug Administration (“FDA”) has approved GARZULYS (insulin apsart-fsan) injection. GARZULYS, a biosimilar to Novo Nordisk’s NOVOLOG® (insulin aspart), is a rapid-acting insulin analog indicated to improve
