Monthly FDA Guidance and Regulatory News Review - February 2026
In February 2026, FDA activity included new draft guidances, regulatory initiatives (e.g., PreCheck...
Tackling the Complexities of Advanced Therapies for Neurology
Developing advanced therapies for neurology is often described as a “perfect storm of complexity.”...
The Compound Effect of Specialized Knowledge
In life, specialized knowledge is required when guesswork is not an option.
Monthly FDA Guidance and Regulatory News Review - January 2026
January 2026 regulatory updates underscored evolving AI-focused policies, ongoing scrutiny of...
Rare Disease Development: Navigating Small Populations and Complex Protocols
Each rare disease may affect only a few thousand, or even a few dozen, people worldwide. Yet...
Monthly FDA Guidance and Regulatory News Review - December 2025
December 2025 capped the year with a robust slate of FDA activity, including multiple final and...
The Science of Simultaneous Submissions: Managing Multiple Regulatory Pathways
Bringing innovative therapies to patients worldwide no longer necessitates sequential engagement...
EU Pharma Package: Key Takeaways for Clinical Evidence & JCA Strategy
Following the political agreement of 11 December 2025 on the EU Pharmaceutical Package, the summary...
Preserving What Matters: How Institutional Knowledge Protects Value Through M&A
Mergers and acquisitions (M&As) are a defining feature of today’s biopharmaceutical landscape. As...
ASH 2025: Interpreting Rapid Change Across Hematology
Returning from the American Society of Hematology Annual Meeting in Orlando, one message was clear:...