| 2024-07-26 07:49:00 |
Eisai Will Seek Re-examination Of Chmp Opinion FÖr Lecanemab
Stockholm , july 26, 2024 /prnewswire/ -- bioarctic ab’s (publ) (nasdaq stockholm: bioa b) partner eisai announced today that they will request re-examination of the committee for medicinal products for human use (chmp’s) negative opinion posted today on the marketing authorization approval (maa) for lecanemab as treatment for alzheimer’s disease in the eu. ’we are surprised and very disappointed by the chmp’s opinion posted today. |
| 2024-07-25 00:58:00 |
Dassault SystÈmes: Eisai Selects Medidata’s Clinical Data Studio To Enhance And Modernize Clinical Trial Efficiency And Patient Experience
Eisai selects medidata’s clinical data studio to enhance and modernize clinical trial efficiency and patient experience |
| 2024-06-09 22:55:00 |
Fda Accepts Filing Of Leqembi® (lecanemab-irmb) Sbla For Iv Maintenance Dosing For The Treatment Of Early Alzheimer’s Disease
Stockholm , june 10, 2024 /prnewswire/ -- bioarctic ab’s (publ) (nasdaq stockholm: bioa b) partner eisai announced today that that the u.s. food and drug administration (fda) has accepted eisai’s supplemental biologics license application (sbla) for less frequent monthly lecanemab-irmb (u.s. brand name: leqembi) intravenous (iv) maintenance dosing. a prescription drug user fee act (pdufa) action date is set for january 25, 2025. |
| 2024-06-09 19:37:00 |
Fda Accepts Eisai’s Filing Of Leqembi® (lecanemab-irmb) Supplemental Biologics License Application For Iv Maintenance Dosing For The Treatment Of Early Alzheimer’s Disease
Tokyo and cambridge, mass., june 09, 2024 (globe newswire) -- eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and biogen inc. (nasdaq: biib, corporate headquarters: cambridge, massachusetts, ceo: christopher a. viehbacher, “biogen”) announced today that the u.s. food and drug administration (fda) has accepted eisai’s supplemental biologics license application (sbla) for monthly lecanemab-irmb (u.s. brand name: leqembi®) intravenous (iv) maintenance dosing. a prescription drug user fee act (pdufa) action date is set for january 25, 2025. leqembi is indicated for the treatment of alzheimer’s disease (ad) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early ad). |
| 2024-06-09 19:30:00 |
Fda Accepts Eisai’s Filing Of Leqembi® (lecanemab-irmb) Supplemental Biologics License Application For Iv Maintenance Dosing For The Treatment Of Early Alzheimer’s Disease
Tokyo and cambridge, mass. , june 9, 2024 /prnewswire/ -- eisai co., ltd. |
| 2023-03-23 08:08:00 |
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| 2023-01-06 23:30:00 |
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| 2023-01-06 14:30:00 |
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| 2022-12-12 09:00:00 |
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| 2022-11-23 18:30:00 |
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| 2022-08-03 19:32:00 |
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| 2022-06-02 19:30:00 |
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| 2021-12-17 06:44:00 |
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| 2021-11-11 11:20:00 |
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| 2021-07-22 07:32:00 |
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