Biogen Provides Update on FDA Advisory Committee Meeting on Tofersen for SOD1-ALS
22 mars 2023 20h31 HE
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Biogen Inc.
CAMBRIDGE, Mass., March 22, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced today the outcome of the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System...
Biogen Receives Favorable Decision from Court of Justice of the European Union Relating to TECFIDERA® (dimethyl fumarate) Regulatory Data and Marketing Protection
16 mars 2023 06h30 HE
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Biogen Inc.
CAMBRIDGE, Mass., March 16, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the Court of Justice of the European Union decided in favor of Biogen, the European Medicines...
Biogen Appoints Chuck Triano as Head of Investor Relations
14 mars 2023 07h30 HE
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Biogen Inc.
CAMBRIDGE, Mass., March 14, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ: BIIB) today announced the appointment of Chuck Triano as Senior Vice President, Head of Investor Relations effective 10...
Caroline Dorsa to Succeed Stelios Papadopoulos as Chair of Biogen Board of Directors
08 mars 2023 07h30 HE
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Biogen Inc.
CAMBRIDGE, Mass., March 08, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (NASDAQ: BIIB) today announced that the Board of Directors has elected Caroline Dorsa as Chair of the Board of Directors, effective...
FDA Accepts Eisai’s Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for the Treatment of Alzheimer’s Disease
05 mars 2023 18h30 HE
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Biogen Inc.
Confirmatory Phase 3 Clarity AD data to be evaluated by FDA in determining whether to convert accelerated approval of LEQEMBI to a traditional approval Priority Review accelerates FDA review...
Biologics License Application for Lecanemab Designated for Priority Review by China National Medical Products Administration
27 févr. 2023 18h30 HE
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Biogen Inc.
TOKYO and CAMBRIDGE, Mass., Feb. 27, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge,...
Biogen and Sage Therapeutics Announce FDA Accepts Filing of New Drug Application and Grants Priority Review of Zuranolone in the Treatment of Major Depressive Disorder and Postpartum Depression
06 févr. 2023 06h30 HE
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Biogen Inc.
Zuranolone is being evaluated as a potential 14-day, rapid-acting, once-daily, oral medication to treat major depressive disorder (MDD) and postpartum depression (PPD)Depression is a public health...
Lecanemab Receives Priority Review Status in Japan
29 janv. 2023 18h30 HE
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Biogen Inc.
TOKYO and CAMBRIDGE, Mass., Jan. 29, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge,...
Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease Accepted by European Medicines Agency
26 janv. 2023 18h30 HE
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Biogen Inc.
TOKYO and CAMBRIDGE, Mass., Jan. 26, 2023 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge,...
Biogen Names Priya Singhal as Executive Vice President, Head of Development
05 janv. 2023 07h30 HE
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Biogen Inc.
CAMBRIDGE, Mass., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that Priya Singhal, M.D., M.P.H., currently Head of Global Safety and Regulatory Sciences and Interim Head of...