On May 28, 2024, the FDA approved Amgen's BKEMV (eculizumab-aeeb), the first approved biosimilar of Alexion's SOLIRIS (eculizumab). BKEMV was approved by the FDA as a 300 mg/30 mL (10 mg/mL)...

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

On January 31, 2025, Celltrion announced that the FDA approved its tocilizumab biosimilar, AVTOZMA® (tocilizumab-anoh), referencing Genentech's ACTEMRA®.

On February 16, 2024, the FDA approved Iovance's AMTAGVI, the first approved cellular therapy for the treatment of adult patients with unresectable or metastatic melanoma.

On March 18, 2024, the FDA approved Orchard Therapeutics' LENMELDY, the first approved gene therapy for the treatment of children with metachromatic leukodysrophy.

On November 25, 2024, Intellia Therapeutics announced that its CRISPR-based therapy, nexiguran ziclumeran...

This month, FDA issued its new final guidance to replace a draft guidance that issued on May 22, 2019 titled "Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment...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

On February 23rd, 2024, Alvotech and Teva announced FDA's approval of SIMLANDI (adalimumab-ryvk), the first high-concentration and citrate-free biosimilar interchangeable with Humira...

In a sealed order that issued last week, the Court has granted a preliminary injunction against Samsung Bioepis in the aflibercept BPCIA litigation brought by Regeneron.

On August 26, 2024, Regeneron filed a BPCIA complaint in the District Court for the District of New Jersey against Sandoz Inc. related to Sandoz's ENVEEZU (aflibercept-abzv).

Bryan Donohoe, Partner, Co-Head of US Real Estate, Ares US Real Estate Adam Gallistel, Regional Head, RE Americas, GIC...

Operational real estate (ORE) has emerged as a focal point for commercial real estate investors eager to transition from passive to active ownership strategies.

On May 7, 2024, the Consumer Financial Protection Bureau (CFPB) announced that it had entered into a consent order with a financial technology company.