fbpx
Subscribe
Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors

Archive

Leqembi (lecanemab) authorized for early alzheimer’s disease in Great Britain – Eisai + Biogen

Written by | 31 Aug 2024

Eisai Co., Ltd. and Biogen Inc. announced that the humanized amyloid-beta (Abeta monoclonal antibody “Leqembi” (brand name, generic name: lecanemab) has been granted a Marketing Authorization by the… read more.

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.

European Commission approves Skyclarys (omaveloxolone) to treat Friedreich’s ataxia – Biogen

Written by | 17 Feb 2024

Biogen Inc. announced the European Commission (EC) has authorized Skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older …. read more.

CHMP issues positive opinion for Skyclarys (omaveloxolone), the first therapy to treat Friedreich’s ataxia, a rare neurodegenerative disease – Biogen

Written by | 20 Dec 2023

Biogen Inc. announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing authorization for Skyclarys (omaveloxolone) for the treatment of… read more.

FDA approves Zurzuvae, the first and only oral treatment for postpartum depression, and issues a complete response letter for major depressive disorder – Sage Therapeutics + Biogen

Written by | 9 Aug 2023

Sage Therapeutics, Inc .and Biogen Inc. announced the FDA approved Zurzuvae (zuranolone) 50 mg for adults with postpartum depression (PPD). Zurzuvae is the first and only oral, once-daily,… 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.

FDA issues complete response letter for Tysabri supplemental filing in SC form for multiple sclerosis – Biogen

Written by | 7 May 2021

Biogen Inc. announced that it has received a Complete Response Letter from the FDA for its supplemental Biologic License Application (sBLA) for a new subcutaneous route of administration… read more.

EU approves SC version of Tysabri for multiple sclerosis – Biogen

Written by | 14 Apr 2021

Biogen announced that the European Commission (EC) has granted marketing authorization for a subcutaneous (SC) injection of Tysabri (natalizumab) to treat relapsing-remitting multiple sclerosis (MS).

FDA approves intramuscular injection route of administration of Plegridy for multiple sclerosis – Biogen

Written by | 9 Feb 2021

Biogen Inc. announced that the FDA has approved a new intramuscular (IM) injection route of administration for Plegridy (peginterferon beta-1a) for the treatment of relapsing forms of multiple… read more.

Newsletter Icon

Subscribe for our mailing list

If you're a healthcare professional you can sign up to our mailing list to receive high quality medical, pharmaceutical and healthcare E-Mails and E-Journals. Get the latest news and information across a broad range of specialities delivered straight to your inbox.

Subscribe

You can unsubscribe at any time using the 'Unsubscribe' link at the bottom of all our E-Mails, E-Journals and publications.