NICE (UK): NICE is unable to make a recommendation on omaveloxolone (Skyclarys) for treating Friedreich’s ataxia in people 16 years and over. This is because Biogen withdrew its… read more.
Biogen Inc. announced that the FDA has accepted the company’s supplemental New Drug Application (sNDA) and the EMA has validated the application for a higher dose regimen of… read more.
Eisai Co., Ltd and Biogen Inc. announced that the latest findings for lecanemab-irmb (U.S. brand name: Leqembi), an anti-amyloid beta (Aβ) protofibril antibody for the treatment of early… read more.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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