📢 FDA Update — February 12, 2026 (Worth Reading for Life Sciences Pros)

Today the U.S. Food and Drug Administration (FDA) announced the approval of a first-of-its-kind device for treating pancreatic cancer — a milestone for a disease with limited therapeutic options. The device delivers tumor treating fields (TTFields) non-invasively and is designed for use in the home, marking a shift toward more patient-centric cancer care. This represents a notable regulatory development in oncology device innovation.

At the same time, the FDA is also stepping up enforcement actions in drug safety and quality:

• The agency has signaled a push to restrict mass-marketed compounded GLP-1 products, emphasizing safety risks and non-compliance with Federal standards amid high demand for weight-loss drugs.
• And — in a rather controversial regulatory move — FDA has refused to file Moderna’s application for a new mRNA-based flu vaccine, citing study design concerns. This decision has sparked industry discussion about future vaccine development expectations.

If you’re working on regulatory strategy, clinical development, or product innovation, these developments are ones to watch — from shifts in review decisions to how the agency balances safety, innovation, and public trust.

What’s your take on the FDA’s recent decisions and enforcement focus?

#FDA #RegulatoryAffairs #LifeSciences #Biotech #MedicalDevices #ClinicalDevelopment