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
How Upcoming Tariffs Could Reshape Drug Pricing, Global Manufacturing, and Supply Chains President Trump’s latest threat to impose tariffs reaching 250% on pharmaceutical imports represents
Quick Summary •Market Reaction: Biotech stocks saw modest gains following Trump’s 2024 election victory, reflecting optimism about regulatory leniency and M&A activity. •Key Appointments: Speculation
