Incubate’s John Stanford on why MFN hits mid-sized pharma harder — fewer products to absorb margin hits and less access to cheap capital.

Fox Rothschild's Marc Wagner on why domestic manufacturing reduces drug shortage risk — and why FDA inspection efficiency is as important as supply chain resilience.

Fox Rothschild's Marc Wagner on how 503A pharmacies and 503B outsourcing facilities fill drug supply gaps — from COVID injectables to GLP-1s.

Fox Rothschild's Marc Wagner on why scaling drug production is so slow — overseas API sourcing, supplier qualification, and FDA site approvals that take years.

Fox Rothschild's Marc Wagner on why the FDA counts 70 drugs in shortage while ASHP counts 188 — and what's driving the gap.

Lilly’s Foundayo receives a positive CHMP opinion for obesity and type 2 diabetes — putting the oral GLP-1 pill on course for EU approval.

The interleukin-6 receptor inhibitor gains a second indication, though one of two phase 3 trials missed its primary endpoint.

European regulators are increasing pressure on clinical trial sponsors to report study results on time, rolling out new monitoring, reminders and guidance as patient advocates welcome the progress but question whether stronger oversight and enforcement will follow.