Field notes from the regulated-writing frontier.
Articles, essays, and technical writeups from the Asthra team and our advisor network. Written for medical writers, regulatory leads, and the people who hold them accountable.
FDA's First Non-Antipsychotic Dementia Agitation Approval Changes Treatment Paradigm
FDA approves Auvelity for Alzheimer's agitation, marking a breakthrough in dementia care. We analyze the regulatory pathway, novel endpoints, and what this means for CNS drug development.
2026
Kymera's KT-621 Fast Track: What Degrader Designations Signal for Respiratory Programs
FDA grants Fast Track to Kymera's IRAK4 degrader KT-621 for eosinophilic asthma. We analyze what this designation reveals about regulatory pathways for targeted protein degradation in respiratory disease.
2026
When Partnerships End, Documentation Inheritance Becomes a Regulatory Burden
Big pharma partnership terminations leave smaller biotechs holding jointly-authored documents that need sponsor re-issue. The regulatory writing burden of these terminations is rarely discussed but significant.
2025
Writer-Defined Provenance: Why Source Control Matters in AI-Assisted Regulatory Writing
How writer-defined provenance ensures that every piece of AI-generated regulatory content is traceable to its specific source document, section, table, or image.
2025
What Is Regulatory Writing Automation in Life Sciences?
A clear definition of regulatory writing automation: what it covers, which documents benefit most, and why the life sciences industry is adopting AI-assisted drafting now.
2025
CSR Timelines: From One Month to Less Than 10 Days
How AI-assisted drafting is compressing Clinical Study Report timelines from weeks of manual effort to days of focused writing, without compromising quality or traceability.