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Videos

In August 2026, Heidi Overton was nominated for FDA commission, and a wave of oncology and neuro drugs were approved.

Regulatory Roundup—August 2026

Chris Williams serves as executive director, Analytical Development ILM at Alcami, bringing more than a decade of experience in analytical development, quality control, and laboratory operations.

He earned a Bachelor of Science in Chemistry in 2010 and a Master of Science in Chemistry in 2011 from East Carolina University. Chris joined AAI, now Alcami, in 2011 as a Development/QC Scientist. In 2013, he began supervising a laboratory team focused on high-throughput manufacturing release. In 2014, he moved into the management of development services and has since progressed to oversee elemental impurities, biologics, extractables and leachables, nitrosamines, specialty testing, raw material release, microbiology, and all Wilmington laboratory operations.

Articles

Nitrosamine control is about understanding why nitrosamines form, where they may form, and how to prevent their formation.

From Detection to Prediction: Analytical Approaches for Nitrosamine Risk

Four FDA approvals in the areas of HIV, diabetes, autoimmune disease, and COVID-19 vaccines came in a flurry in late August 2026. 

What to Know from the FDA’s End of August Activity

This week’s PharmTech.com content covered AI agent authority, hold-time and nitrosamine risk frameworks, biologics formulation, 3D bioprinting, and major oncology and dealmaking news.

PharmTech Weekly Roundup—August 28, 2026

Robert Dream is managing director of HDR Company and a member of PharmTech’s Editorial Advisory Board. 

In part 2 of his overview on hold times in biopharmaceuticals, Robert Dream details the regulations that govern hold times and how to mitigate risks that can occur during hold times.

Pharma Fundamentals: Risks and Regulations for Hold Times in Biopharmaceuticals

Brian Drapeau is founder, GxPFrame and a cell and gene therapy manufacturing and quality systems consultant.
He can be contacted at bdrapeau@gxpframe.com for any consulting or advisory needs. 

Agentic AI changes the question from what a model can produce to what a system is allowed to decide.

Pharma's Next AI Problem Is Authority

FDA approves Rasonque (daraxonrasib), the first broad RAS-targeted therapy for metastatic pancreatic cancer, validating RAS(ON) inhibition for future drug development.

Rasonque's 60% Survival Benefit: What It Means for Oncology Pipelines

FDA priority review of Jemperli for biomarker-defined rectal cancer signals capacity, supply chain, and global filing shifts for manufacturers.

GSK's Jemperli Rectal Cancer Filing Signals Biologics Capacity Shift

REGENXBIO's RGX-121 faces an FDA clinical hold after asymptomatic spine MRI findings, highlighting long-term imaging surveillance for CNS gene therapies.

Must-Knows from the RGX-121 Hold

The FDA grants accelerated approval to Ultragenyx's Genglycos, the first gene therapy for GSDIa, raising manufacturing and post-market monitoring questions.

Quality Systems