The US Food and Drug Administration has announced a renewed focus on a long-considered issue—whether FDA should release complete response letters (CRLs) issued to drug or biologic applicants. Specifically, on July 10, 2025...more
The US Securities and Exchange Commission (SEC) brought a number of notable enforcement proceedings against public companies in fiscal year 2024, which ended September 30, 2024, and into the first quarter of fiscal year 2025....more