Press Releases
| Su | Mo | Tu | We | Th | Fr | Sa |
|---|---|---|---|---|---|---|
| Su | Mo | Tu | We | Th | Fr | Sa |
|---|---|---|---|---|---|---|
-
Jul 26, 2017- First antiepileptic drug (AED) to apply FDA's regulatory pathway of extrapolation for monotherapy use; FDA proposed using this pathway to get monotherapy options to patients sooner
Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) for FYCOMPA® (perampanel) CIII as monotherapy use...
-
Jul 25, 2017- Filing based on positive pivotal Phase 3 trial demonstrating non-inferior overall survival compared to sorafenib
Eisai Inc. today announced it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the first-line use of lenvatinib (marketed as Lenvima®), the...
-
Jul 17, 2017
Eisai Inc. announced today the presentation of eight posters, including safety data on three different compounds in its Alzheimer's disease portfolio, at the Alzheimer's Association International...
-
Jun 21, 2017Lorcaserin Phase IIIb/IV Outcomes Study Assesses Incidence of Major Adverse Cardiovascular Events (MACE) in Patients with Overweight or Obesity
Eisai Inc. today announced that the ongoing investigational CAMELLIA-TIMI 61 study of lorcaserin (marketed as BELVIQ® CIV) will continue as planned, based on the recommendation of an independent...
-
Jun 4, 2017- Lenvatinib is the first systemic therapy to demonstrate non-inferiority to sorafenib in the primary efficacy endpoint of overall survival
Eisai Inc. today announced results from the REFLECT study (Study 304), a Phase 3 trial evaluating lenvatinib (marketed as Lenvima®), the company's multiple receptor tyrosine kinase inhibitor...