Compounding at a Crossroads: Why Safety Standards Are the Industry's Best Defense

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.

FDA is launching the Rare Disease Framework Initiative, aiming to tailor drug development and review requirements to the realities of small patient populations.

TRexBio and Retension Pharmaceuticals priced IPOs, raising a combined $161.7 million to advance their immunology and hypertension pipelines ahead of their Nasdaq debuts.

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.

Why “we’re safe” is the most dangerous assumption in medical benefit commercialization.

Fox Rothschild's Mark Wagner on why drug shortages are so hard to fix — from the definition gap to API dependency to three-year site approvals.

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