Regulatory Actions for June 2026

In regulatory news in June 2026, the US FDA accepted the first in silico drug development tool as part of its ISTAND program, approved a variety of drugs that included treatments for rare conditions, and issued guidance on the acceleration of cell and gene therapy.

On June 3, 2026, the agency accepted a letter of intent for an in silico drug development tool (DDT) into its Innovative Science and Technology Approaches for New Drugs (ISTAND) DDT Qualification Program.¹ The DDT is an artificial intelligence-driven digital liver model that predicts drug induced liver injury and will help reduce the use of animals in a nonclinical space and improve predictive toxicology in humans.

In an FDA Voices blog post posted June 8, Dr. Iilun Murphy, director Office of Generic Drugs, Center for Drug Evaluation and Research (CDER), and Dr. Mike Kopcha, director Office of Pharmaceutical Quality, CDER, provided insight into the agency’s approach to generic drug oversight.² Murphy and Kocha acknowledged that the manufacturing of generic drugs is complex and encouraged manufacturers to adopt mature quality management practices beyond what is required by current good manufacturing practices. They also restated the FDA’s support for onshore manufacturing.

The over-the-counter (OTC) intranasal naloxone product, Rextovy, was approved by the FDA on June 16, 2026 for the emergency treatment of opioid overdose.³ The action is part of FDA’s priority to reduce opioid deaths by broadening access to these types of treatments that rapidly reverse the effects of opioid overdose.

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