Coverage of FDA decisions, advisory committees, submissions, guidances, policy changes, and global regulatory developments shaping the health science industry.
Vepdegestrant PROTAC estrogen receptor degrader targets ER+ breast cancer with novel mechanism The FDA accepted Arvinas and Pfizer’s New Drug Application for vepdegestrant (ARV-471), granting
Thermo Fisher’s companion diagnostic enables precision treatment with zongertinib for rare NSCLC subset The FDA approved Thermo Fisher Scientific’s Oncomine Dx Target Test as a
PharmaTher’s KETARx becomes first FDA-approved ketamine formulation for on-label surgical use In a historic regulatory milestone, the FDA approved PharmaTher’s KETARx on August 8, 2025,
Healthcare policy analysts are projecting potentially significant premium increases of up to 20% for Affordable Care Act (ACA) marketplace plans in 2026, driven by a
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled an innovative Early Access program that will allow certain high-priority medical devices to enter
The Federal Trade Commission has filed a lawsuit to prevent Edwards Lifesciences from completing its $945 million acquisition of JenaValve Technology, marking a significant regulatory
The FDA has unveiled its ambitious PreCheck program, a strategic initiative designed to fast-track the regulatory review of pharmaceutical manufacturing facilities and strengthen America’s domestic
The Ruling’s Ripple Effect for SDK-Based Data Harvesting in Digital Health A landmark court ruling finding Meta liable for improperly collecting sensitive reproductive health data
Implications for Future Pandemic Readiness and Platform Vaccine Funding The Department of Health and Human Services’ decision to terminate multiple pandemic-era mRNA vaccine development programs
How the GAO’s Illegal Withholding Decision Changes NIH Leverage Over Grantees The Government Accountability Office’s (GAO) bombshell ruling that the National Institutes of Health violated
