This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
News|Videos|August 31, 2026
Regulatory Roundup—August 2026
Author(s)Susan Haigney
In August 2026, Heidi Overton was nominated for FDA commission, and a wave of oncology and neuro drugs were approved.
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In August 2026, a new FDA commissioner was nominated by the White House; there was a variety of novel drug approvals spanning oncology to narcolepsy; and parallel moves from the United Kingdom's MHRA and Europe's EDQM were made to modernize standards—all set against tightened manufacturing scrutiny on both sides of the Atlantic.
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Boyang Wang, Immortal Dragons, explains how FDA’s Expedited IND Pilot and research partners could speed serial steps to first-in-human trials compared to China’s 818 Decree.
Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.
This week, drug formulation and manufacturing experts showcased their knowledge, and companies exhibited their products, at CPHI Milan.
FDA approves Teva’s Weltruza, a once-monthly subcutaneous olanzapine for schizophrenia whose copolymer depot eliminates post-injection monitoring.
Ron Scarboro, Azurity Pharmaceuticals, explains when formulation robustness justifies added cost and which post-approval quality and supply metrics teams can track.
Richard Jaenisch explains why NAMs are compressing drug development faster than AI and what FDA's new nonclinical testing rule means for sponsors.
Ron Scarboro, Azurity Pharmaceuticals, claims drug reformulation that removes patient barriers must preserve efficacy, urging early cross-functional team alignment.
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