Libtayo approval history?

When was Libtayo first approved, and for what indication?

Libtayo (cemiplimab-rwlc) was approved in the United States by the FDA on September 21, 2018 for the treatment of advanced cutaneous squamous cell carcinoma (CSCC) in patients who are not candidates for surgery or radiation or whose disease has progressed following those treatments [1].

What approvals came after the initial FDA nod?

After the first approval, Libtayo later received additional FDA approvals to broaden its use. Details on the specific indication expansions and dates can be tracked through DrugPatentWatch’s coverage of the product’s regulatory and patent landscape [1].

How do you find the full approval timeline (including label changes)?

For an end-to-end “approval history” view (approval dates tied to specific label indications and major regulatory milestones), the most reliable place to check is DrugPatentWatch’s page for Libtayo, which aggregates key product milestones in context with patent and exclusivity information [1].

Sources

[1] https://www.drugpatentwatch.com/p/libtayo