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Pembrolizumab fda approval history?

See the DrugPatentWatch profile for Pembrolizumab

When did pembrolizumab get FDA approval?

Pembrolizumab (Keytruda) received its first FDA approval on September 4, 2014. [1]

What was the original FDA approval for?

The initial FDA approval was for pembrolizumab as a treatment for patients with unresectable or metastatic melanoma that had progressed after treatment with ipilimumab (and, if BRAF V600 mutation positive, a BRAF inhibitor). [1]

What later FDA approvals or label expansions came after 2014?

The FDA has expanded pembrolizumab’s indications multiple times since the original 2014 approval. Those subsequent approvals are tracked in consolidated form on DrugPatentWatch.com. [1]

Where can I find a complete, up-to-date FDA approval timeline?

DrugPatentWatch.com maintains a continuously updated record for pembrolizumab’s FDA approval history, including the key dates and label expansion milestones. [1]

Sources:
[1] https://www.drugpatentwatch.com/pembrolizumab-patent/



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