Regulatory
Showing all blog posts in the Regulatory category.
regulatory
FDA Says Retatrutide Is a Drug, Not a Biologic: What It Means
On October 2, 2026 the FDA ruled retatrutide is a drug, so it must be filed as an NDA, not a BLA. The 40-amino-acid rule, the court case and what changes.
| 9 min
regulatory
Retatrutide Expanded Access: Who Qualifies and How Doctors Apply
Lilly's pre-approval program (NCT07629401) is for BMI 35+ despite approved drugs, two serious complications and no trial nearby. Only doctors can apply.
| 7 min
regulatory
Retatrutide in the UK and Europe: Regulatory Pathway and Expected Timeline
Retatrutide is not approved in the UK or EU. How the MHRA, EMA and NICE steps work, and our estimate of when it could reach patients (late 2028 UK, 2029 EU).
| 8 min
regulatory
Retatrutide FDA Approval Timeline: When Will It Be Available?
Lilly plans to file by Q1 2027, and the FDA says the application must be an NDA. Review takes 8 to 12 months, so here are the realistic approval dates.
| 8 min