United States: Food and Drugs Law

On December 2, 2025, Governor Pritzker signed HB 767 into law, amending powers of the Illinois Department of Public Health ("IDPH"). HB 767 creates an independent mechanism for Illinois to develop vaccine...

Over the next 12–18 months, healthcare providers can expect meaningful updates to the Health Insurance Portability and Accountability Act (HIPAA) affecting reproductive health information, security controls...

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

The U.S. Food and Drug Administration (FDA) recently released a draft guidance Q&A offering clarity to the industry on FDA's implementation of its new authority...

On December 3, 2025, the U.S. Food and Drug Administration held its public meeting on the upcoming reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2028–2032...

On December 1, 2025, the President signed into law the SUPPORT for Patients and Communities Reauthorization Act, a significant legislative development aimed at expanding...

OptumRx's decision to implement a 25 percent therapeutic class cap for network pharmacies beginning in 2026 marks an important moment in the continuing evolution of pharmacy benefit manager (PBM) oversight.

The Internal Revenue Service (IRS) has provided guidance on the changes made to the rules governing health savings accounts (HSAs) in the One Big Beautiful Bill, which was enacted this summer.

Today, President Trump signed a long-anticipated executive order (EO) directing the Attorney General to "take all necessary steps to complete the rulemaking process related...