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FDA grants accelerated approval for ADUHELM™ as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease
June 7, 2021 - … FDA grants accelerated approval for ADUHELM™ as the first and only Alzheimer’s disease treatment … of the disease FDA grants accelerated approval for ADUHELM™ as the first and only Alzheimer’s disease treatment … pathology of Alzheimer’s disease In clinical trials, ADUHELM reduced amyloid beta plaques by 59 to 71 percent at …
A Letter from Biogen’s CEO on ADUHELM
June 7, 2021 - … A Letter from Biogen’s CEO on ADUHELM A Letter from Biogen’s CEO on ADUHELM June 7, 2021 Company Statements General Today, on … Administration (FDA) has granted accelerated approval for ADUHELM™ (aducanumab-avwa), the first-ever therapy to address …
An open letter to the Alzheimer’s disease community from our Head of Research and Development, Alfred Sandrock, M.D., Ph.D.
July 22, 2021 - … M.D., Ph.D. July 22, 2021 News Release General NOTE: ADUHELM TM (aducanumab-avwa) injection 100 mg/mL solution is … for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive … in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be …
Biogen Statement Regarding Updated ADUHELM® (aducanumab-avwa) Prescribing Information in US
April 29, 2022 - … Biogen Statement Regarding Updated ADUHELM® (aducanumab-avwa) Prescribing Information in US Biogen Statement Regarding Updated ADUHELM® (aducanumab-avwa) Prescribing Information in US … has approved an updated full Prescribing Information for ADUHELM (aducanumab-avwa) 100 mg/mL injection for intravenous …
Biogen To Offer Continuity of Care Plan for U.S. Patients Currently Treated with ADUHELM® (aducanumab-avwa)
April 28, 2022 - … of Care Plan for U.S. Patients Currently Treated with ADUHELM® (aducanumab-avwa) Biogen To Offer Continuity of Care Plan for U.S. Patients Currently Treated with ADUHELM® (aducanumab-avwa) April 28, 2022 Company Statements … announcing plans to help patients in the U.S. currently on ADUHELM avoid any treatment interruptions following the final …
Biogen and Eisai Update for the Alzheimer’s Disease Community
June 23, 2021 - … today issued the following statement: On June 7, 2021, ADUHELM™ (aducanumab-avwa) 100 mg/mL solution for injection … and providing more details about our plans. About ADUHELM treatment and the confirmatory trial ADUHELM is indicated for the treatment of Alzheimer’s …
FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials
July 8, 2021 - … FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population … in Clinical Trials July 8, 2021 News Release General ADUHELM should be initiated in patients with mild cognitive …
Biogen and Eisai Announce Design of ADUHELM ICARE AD-US Study, the First Real-World Observational Phase 4 Study in Alzheimer’s Disease at AAIC 2021
July 29, 2021 - … Biogen and Eisai Announce Design of ADUHELM ICARE AD-US Study, the First Real-World Observational … Disease at AAIC 2021 Biogen and Eisai Announce Design of ADUHELM ICARE AD-US Study, the First Real-World Observational … study designed to evaluate the safety and effectiveness of ADUHELM in clinical practice ICARE AD-US is one of three …
Biogen Announces Peer-Reviewed Publication of ADUHELM® Phase 3 EMERGE and ENGAGE Data in The Journal of Prevention of Alzheimer’s Disease
March 16, 2022 - … Biogen Announces Peer-Reviewed Publication of ADUHELM® Phase 3 EMERGE and ENGAGE Data in The Journal of … Disease Biogen Announces Peer-Reviewed Publication of ADUHELM® Phase 3 EMERGE and ENGAGE Data in The Journal of … data from the pivotal Phase 3 EMERGE and ENGAGE trials for ADUHELM ® (aducanumab-avwa) 100 mg/mL injection for …
Update on Regulatory Submission for Aducanumab in the European Union
April 22, 2022 - … options to people living with Alzheimer’s disease. ADUHELM (aducanumab-avwa) was approved by the U.S. Food and … details on the indication are provided below. About ADUHELM® (aducanumab-avwa) injection 100 mg/mL solution for intravenous use In the U.S., ADUHELM (aducanumab-avwa) injection 100 mg/mL solution for …
