Regulatory
Showing all blog posts in the Regulatory category.
regulatory
Retatrutide Expanded Access: Who Qualifies and How Doctors Apply
Lilly's pre-approval program (NCT07629401): BMI 35+ despite maximal approved therapy, two serious complications, no accessible trial. Physician-requested only.
| 7 min
regulatory
Retatrutide in the UK and Europe: Regulatory Pathway and Expected Timeline
Retatrutide is not approved in the UK or EU as of 2026. Covers MHRA and EMA pathways, expected timelines (late 2028 UK, 2029 EU), and NICE assessment.
| 8 min
regulatory
Retatrutide FDA Approval Timeline: When Will Retatrutide Be Available?
Updated September 2026: all five pivotal trials reported, BLA planned for Q1 2027, earliest FDA decision late 2027 (Priority Review) or the first half of 2028.
| 8 min