News: approvals, trials, safety and access
Original summaries of verified developments, each with its event date, the sources beside the claims they support, why it matters and what remains uncertain. Old events that are newly written up keep their original event dates.
Retatrutide: Lilly plans a US submission in Q1 2027. What that does and does not tell you
Announcing two further Phase 3 results on 23 July 2026, Lilly said it planned to submit retatrutide to the FDA in the first quarter of 2027. GLPInfo shows this as a company target and keeps its conditional approval scenario in the detail view only.
FDA approves Foundayo (orforglipron), the first oral small-molecule GLP-1 medicine for weight management
On 1 April 2026 the FDA approved Foundayo, Eli Lilly's once-daily oral orforglipron, for adults with obesity or with overweight and a weight-related condition. UK and EU status are separate records and are verified independently.
CagriSema was submitted to the FDA in December 2025. A submission is not an approval
Novo Nordisk's 2025 annual report states that CagriSema, its cagrilintide and semaglutide combination, was submitted to the FDA in December 2025 for weight management. GLPInfo records this as a submission event and is verifying the latest disposition before showing any status or forecast.
Wegovy's cardiovascular indication: what the US, UK and EU each decided in 2024
In 2024 the same trial, SELECT, produced three different regulatory outcomes for semaglutide (Wegovy): a new indication in the US on 8 March, a new indication in the UK on 23 July, and a product-information update in the EU. Here is what each one means.
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