Glass Lewis is transforming its proxy advisory approach by moving away from a single global voting policy toward a multi-perspective framework that offers four distinct viewpoints tailored to different client priorities. The new system, set to launch in September 2027, will provide perspectives ranging from business fundamentals to sustainability-focused governance, allowing institutional investors to align proxy research with their specific investment philosophies.

The New York Stock Exchange has proposed extending the timeline for newly public companies to establish internal audit functions from one year to five years post-listing.

Nasdaq's new $5 million Market Value of Listed Securities requirement faces an automatic stay following petitions for SEC review. The rule would have immediately suspended and delisted companies falling below the threshold, but its implementation now hangs in regulatory limbo as the Commission weighs whether to affirm or overturn the Division of Trading and Markets' approval.

We recently published a client alert on the SEC’s proposal to eliminate the longstanding “baby shelf” limitations and significantly expand access to Form S-3 and shelf registration for public companies.

On June 16, 2025, the FTC announced ​it had reached a settlement ​with a UK-based payment processor, resolving allegations that the company...

On June 12, 2025, BioNTech SE ("BioNTech") announced its entry into a definitive purchase agreement to acquire all shares of CureVac N.V. ("CureVac"), with an implied aggregate equity value for CureVac of approximately $1.25 billion.

Eli Lilly announces a definitive agreement to acquire Merida Biosciences for up to $2.875 billion in cash, gaining access to an innovative antibody-engineering platform that selectively targets pathogenic autoantibodies in autoimmune and allergic diseases. The acquisition includes Merida's lead program MER511, currently in Phase 1 development for Graves' disease and thyroid eye disease, along with earlier-stage programs addressing food allergy, asthma, and kidney disease.

On April 1, 2025, the European Medicines Agency opened the consultation period for its draft reflection paper on a tailored clinical approach in biosimilar development.

On February 13, 2026, STADA and Bio-Thera announced that they have received European Marketing Authorization for GOTENFIA®, a golimumab biosimilar to Johnson & Johnson's SIMPONI®.

Dr. Reddy's Laboratories ("Dr. Reddy's") announced on February 22 that the FDA accepted its BLA for DRL_AB, a proposed interchangeable biosimilar to Bristol-Myers Squibb's ORENCIA® (abatacept) IV for infusion.

On May 19, Novavax, Inc. ("Novavax") announced that FDA approved its Biologics License Application ("BLA") for Nuvaxovid™ for active immunization...

This month, FDA issued its new final guidance to replace a draft guidance that issued on May 22, 2019 titled "Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment...

On October 17, 2025, Amgen and AstraZeneca announced that the FDA has approved an additional indication for TEZSPIRE (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled...

On November 17, 2025 Formycon AG ("Formycon") announced development of a dupilumab biosimilar, FYB208, referencing Regeneron and Sanofi's DUPIXENT.

The U.S. Department of Health and Human Services has announced the termination of COVID-19 Emergency Use Authorization declarations, marking a significant shift in how COVID-19 medical products will be regulated. With FDA-approved treatments now widely available, manufacturers must navigate new regulatory pathways as the emergency framework that enabled rapid pandemic response comes to an end.

Outlook Therapeutics has achieved a significant regulatory milestone with FDA approval of LYTENAVA™, the first ophthalmic formulation of bevacizumab specifically developed for treating neovascular age-related macular degeneration. While bevacizumab has been used off-label in retina care through repackaged oncology formulations, this marks the first FDA-approved version designed specifically for intravitreal ophthalmic use, with the product expected to receive 12 years of exclusivity under the BPCIA.

On October 21, 2025, GSK announced that the European Medicine Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") adopted a positive opinion for the shingle vaccine SHINGRIX...

On November 17, 2025, Sandoz announced the launch of TYRUKO® (natalizumab-sztn) in the United States as the first and only biosimilar for the treatment of relapsing forms of multiple sclerosis.

On December 1, 2025, Sun Pharmaceutical Industries Ltd. ("Sun Pharma") announced the launch of ILUMYA® (tildrakizumab-asmn) in India. ILUMYA® is a humanized monoclonal antibody injection indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy

Last week, Takeda announced that it has entered into a worldwide license and collaboration agreement (outside of Greater China) with Innovent Biologics for the development, manufacture, and commercialization...