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ASCO 2026: RAS Is No Longer Undruggable
June 15, 2026
For decades, oncologists and drug developers shared an undeniable truth: KRAS – one of the most commonly mutated genes in human cancer – was untargetable. Mutations in KRAS drive approximately 25% of all cancers, including most pancreatic...
4 min read
Monthly FDA Guidance and Regulatory News Review - May 2026
June 12, 2026
This May 2026 regulatory update highlights multiple guidances issued by the FDA across cell and gene therapy, clinical development, and pharmaceutical quality. The FDA also released new draft guidances focused on pain management, stimulant use disorders,...
3 min read
Clear, Inclusive, Human: The Lay Language Shift Reshaping Clinical Communications
June 11, 2026
Key insights from my presentation at the AMWA Carolinas Spring 2026 Conference on the evolving global expectations for patient-facing clinical content
2 min read
Scaled complex patient narrative generation with consistent, high-quality outputs
June 11, 2026
Best Practices for Safety Narrative Writing in Clinical Research
3 min read
Monthly FDA Guidance and Regulatory News Review - April 2026
May 20, 2026
This April 2026 regulatory update highlights new policies on biomarker validation, expanded access to investigational drugs, genome editing safety assessments, and antibiotic impurity specifications. It also summarizes major FDA and industry...
2 min read
Measuring What Can't Be Seen: How PTSD Clinical Trials Prove a Drug Works
April 27, 2026
When an oncology drug is tested, the signal is often brutally clear. A tumor either shrinks on a scan or it does not. A patient either lives or does not. In psychiatric drug development, the endpoints are almost never so crisp. In PTSD trials in...
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The Psychedelic Setback: What MDMA Rejection Taught Drug Developers
April 24, 2026
In August 2024, the FDA declined to approve MDMA-assisted therapy for post-traumatic stress disorder. The decision followed a June advisory committee meeting in which panelists voted nine to two that the data had not shown MDMA was effective, and ten to...
4 min read
Monthly FDA Guidance and Regulatory News Review - March 2026
April 6, 2026
March 2026 regulatory updates underscore newly published final and draft guidances focused on real-world data, safety reporting, biosimilars, CGMP inspections, and innovative drug development methods. It also highlights industry news and regulatory...