Regulatory Articles

  1. Bravo, FDA For Retiring 'Animal Testing' In Favor Of 'Nonclinical' 9/28/2026

    HHS is advancing human-based drug research through new FDA terminology, NIH infrastructure, CDC studies, and ARPA-H tools that reduce reliance on animal testing.

  2. The Continuing Challenge Of Drug-Induced Liver Injury 9/24/2026

    Recent liver safety concerns highlight the limits of conventional preclinical testing. Human-relevant models could help researchers detect drug-induced liver injury earlier and reduce costly setbacks.

  3. Wall Street Is Wary Of NAMs — And For Good Reason: What Happens To Yesterday's Drugs? 9/15/2026

    Part 2 follows the consequences into Wall Street, asking what better evidence could mean for pharmaceutical valuations and, ultimately, drugs already in the portfolio.

  4. Wall Street Is Wary Of NAMs — And For Good Reason: The Evidentiary Shift 9/10/2026

    Part I of this series focuses on the evidentiary shift of how NAMs may change the architecture of evidence and how that transition unfolds.

  5. What The China Biotech Debate Reveals About U.S. Drug Discovery 8/17/2026

    Peter Kolchinsky and Jason Kelly sparred over China’s biotech rise and what it means for U.S. drug discovery, investment, and strategic control.

  6. July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing 8/7/2026

    Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.

  7. Why Ending Rh Disease Requires More Than A Breakthrough (Part 3 of 3) 8/5/2026

    Rh disease has been preventable for decades. Yet babies still die worldwide because access, supply, and infrastructure have not caught up.

  8. Chinese Competition And The Future Of Science: Insights From The U.S. Science Summit 7/24/2026

    At BiotechTV’s U.S. Science Summit, biotech leaders discussed China, AI, scientific storytelling, and what it will take to protect U.S. innovation.

  9. From Path Dependency To Demonstrable Progress: FDA Modernization Act 3.0 7/23/2026

    With House passage of the FDA Modernization Act 3.0, Congress has taken another major step toward modernizing biomedical research and drug development.

  10. Rhogam's Unconventional History And Why There Is No True Synthetic Replacement (Part 2 of 3) 7/17/2026

    Rhogam transformed Rh disease prevention, but its plasma-derived, polyclonal biology has resisted decades of synthetic anti-D replacement efforts.