Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Biotech companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Regeneron. FDA records under 4 spellings of its name, each linked to the record. See the Regeneron group view.
As of Nov 15, 2026, FDA's public records list Regeneron Pharmaceuticals with 9 drug applications, 5 complete response letters and 3 drug recalls. The most recent is a drug recall dated Jul 28, 2026: Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion Af….
Drug applications: 9
Complete response letters: 5
Drug recalls: 3
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
12017Records1
120182018Records1vs 2017+0
02019Records0vs 2018−1
120202020Records1vs 2019+1
12021Records1vs 2020+0
020222022Records0vs 2021−1
32023Records3vs 2022+3
520242024Records5vs 2023+2
12025Records1vs 2024−4
220262026 to dateRecords2
Latest Records
Newest first across sources; each opens the record
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata.How this page is built
