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.

On January 8, 2024, Merck announced its plans to acquire cancer drug developer Harpoon Therapeutics, Inc. for $23.00 per share in cash...

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...

Meitheal and Tonghua Dongbao will be jointly responsible for development and supply, with the expectation of achieving FDA approval in 2026.

The US FDA has accepted a Biologics License Application (BLA) from Sandoz for a proposed denosumab biosimilar. In its press-release, Sandoz stated that the "application includes all indications...

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...

We previously reported on Bristol-Myers Squibb's ("BMS") complaint alleging AstraZeneca's PD-L1 antibody product, IMFINZI (durvalumab), infringed U.S. Patent No. 9,402,899

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).

Last week, Samsung Bioepis filed an IPR petition challenging claims of U.S. Patent No. 11,253,572 ("the '572 patent"), owned by Regeneron Pharmaceuticals.

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.

RECM 2023 | Featured Speaker, Roger Morales.

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

Companies using generative AI should take steps before, during, and after writing code to avoid infringing copyrights on open source software.