Regulatory news
Every regulatory development we have covered, newest first.
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7 dated regulatory items. Most recent: FDA proposes excluding tirzepatide from the 503B bulks list (2026-06-01).
Stories in this category
FDA proposes excluding tirzepatide from the 503B bulks list
If finalised, outsourcing facilities would lose a pathway for compounding at scale.…
State action against a telehealth company's own compounding pharmacy
When the platform and the pharmacy are the same business, a regulatory action lands directly on …
First oral GLP-1 for weight loss approved, priced from $149
A daily tablet reaches the market at a fraction of injectable brand pricing, with a smaller effe…
FDA issues warning letters to compounded GLP-1 marketers
Several telehealth companies were cited over labelling and marketing claims, not over patient ha…
A year after the shortage was declared over, the market has restructured
Scope narrowed and large platforms exited, but patient-specific compounding continues.…
Semaglutide approved for MASH with moderate to advanced fibrosis
The first GLP-1 with an FDA liver indication — and a coverage route that weight management is no…
Zepbound approved for obstructive sleep apnoea
A discrete diagnosis with an approved indication is a stronger prior-authorisation argument than…
Open these rather than taking our word for it. Every one is a regulator, a trial registry, a label, an accreditor or the manufacturer.