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FDA accepts filing of Leqembi (lecanemab-irmb) supplemental biologics license application for IV maintenance dosing for the treatment of early Alzheimer’s disease – Eisai + Biogen

Written by | 26 Jun 2024

Eisai Co. Ltd. and Biogen Inc. announced that that the FDA has accepted Eisai’s Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: Leqembi) intravenous (IV)… read more.

Eisai initiates rolling biologics license application to FDA for Leqembi (lecanemab-irmb) for subcutaneous maintenance dosing for the treatment of early Alzheimer’s disease under the Fast Track status

Written by | 27 May 2024

-Eisai Co., Ltd. and Biogen Inc. announced that Eisai has initiated the rolling submission of a Biologics License Application (BLA) to the FDA for lecanemab-irmb (U.S. brand name:Leqembi)… read more.

Fycompa (perampanel hydrate) is approved in China for adjunctive treatment of primary generalised tonic-clonic seizures – Eisai

Written by | 21 May 2024

Eisai announces approval in China for the additional indication of its in-house discovered antiepileptic drug (AED) Fycompa (generic name: perampanel hydrate) for adjunctive treatment of primary generalized tonic/clonic… read more.

Metoject subcutaneous injection pen (methotrexate) pen – type autoinjector approved in Japan – Eisai

Written by | 24 Feb 2024

Eisai Co., Ltd. and nippon medac Co., Ltd., a subsidiary of medac Gesellschaft für klinische Spezialpräparate mbH announced that they have obtained manufacturing and marketing approval from the… read more.

Update on the phase IV confirmatory study of Aduhelm for Alzheimer’s disease – Biogen + Eisai

Written by | 31 Jan 2022

Biogen Inc. and Eisai Co., Ltd. provided an important update on the continuing progress of the Phase IV post-marketing confirmatory study of Aduhelm (aducanumab-avwa) 100 mg/mL injection for… read more.

FDA grants accelerated approval for Aduhelm to treat Alzheimer’s disease – Biogen + Eisai

Written by | 15 Jun 2021

Biogen and Eisai, Co., Ltd. announced that the FDA has granted accelerated approval for Aduhelm (aducanumab-avwa) as the first and only Alzheimer’sdisease treatment to address a defining pathology… read more.

Real world study of Halaven in breast cancer published in Advances in Therapy – Eisai

Written by | 24 May 2021

Eisai announced results from a real-world study assessing treatment patterns and clinical outcomes with Halaven (eribulin mesylate) injection as a third-line therapy or greater in patients with metastatic… read more.

FDA grants priority review to Keytruda + Lenvima for advanced endometrial carcinoma – Merck Inc + Eisai

Written by | 20 May 2021

Merck Inc and Eisai announced that the FDA has accepted and granted priority review for an application seeking new approval for the combination of Keytruda (pembrolizumab) plus Lenvima… read more.

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