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Celebrating the Successes of ALS Research Today, While Working to Fund More for the Future

mayo 9, 2023 Comentarios desactivados en Celebrating the Successes of ALS Research Today, While Working to Fund More for the Future

This last year has seen incredible progress in the fight to create a world without ALS. The FDA approval of Relyvrio (AMX0035) in 2022 and Qalsody (tofersen) last month are…

Regenerative Medicine: A New Path for ALS Treatment

mayo 1, 2023 Comentarios desactivados en Regenerative Medicine: A New Path for ALS Treatment

A first-of-its-kind stem cell therapy for ALS passes a critical safety benchmark, advancing the search to slow down, reverse and prevent the disease. In a parallel study, investigators are growing…

FDA approves treatment of ALS associated with a mutation in the SOD1 gene

abril 27, 2023 Comentarios desactivados en FDA approves treatment of ALS associated with a mutation in the SOD1 gene

On April 25, 2023, the US Food and Drug Administration (FDA) announced that Qalsody (tofersen) HAS BEEN APPROVED as a new prescription therapy for the treatment of people with rare…

FDA Grants Accelerated Approval for QALSODY™ (tofersen) for SOD1-ALS, a Major Scientific Advancement as the First Treatment to Target a Genetic Cause of ALS

abril 25, 2023 Comentarios desactivados en FDA Grants Accelerated Approval for QALSODY™ (tofersen) for SOD1-ALS, a Major Scientific Advancement as the First Treatment to Target a Genetic Cause of ALS

CAMBRIDGE, Mass., April 25, 2023 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) has approved QALSODY™ (tofersen) 100 mg/15mL injection for…

The Golden West Chapter Congratulates the 2023 Sheila Essey Award for ALS Research and the Richard Olney MD, Clinician-Scientist Development Award Recipients

abril 7, 2023 Comentarios desactivados en The Golden West Chapter Congratulates the 2023 Sheila Essey Award for ALS Research and the Richard Olney MD, Clinician-Scientist Development Award Recipients

Since 1996, the Sheila Essey Award for ALS Research  has been presented to acknowledge and honor an individual who is making significant contributions and breakthroughs in the search for the…

Critical Importance of FDA AdComm Meeting for ALS Therapy NurOwn

abril 3, 2023 Comentarios desactivados en Critical Importance of FDA AdComm Meeting for ALS Therapy NurOwn

NurOwn (BrainStorm Cell Therapeutics) is an investigational therapy made up of autologous mesenchymal stromal cells secreting neurotrophic factors cells (MSC-NTF) for the potential treatment of amyotrophic lateral sclerosis (ALS) and…

Cytokinetics Announces COURAGE-ALS Met Criteria for Futility at Second Interim Analysis

marzo 31, 2023 Comentarios desactivados en Cytokinetics Announces COURAGE-ALS Met Criteria for Futility at Second Interim Analysis

Cytokinetics recently announced the discontinuation of Phase 3 Clinical Trial of Reldesemtiv and thanks the people with ALS, caregivers, investigators, and clinical trial staff for their participation in COURAGE-ALS.

Here’s Why FDA Committee’s Recommendation on Tofersen Matters to Everyone

marzo 24, 2023 Comentarios desactivados en Here’s Why FDA Committee’s Recommendation on Tofersen Matters to Everyone

The FDA advisory committee vote on tofersen Wednesday was an exciting and critical moment in the ALS community’s efforts to find new treatments and cures. The committee voted unanimously to…

FDA Committee Unanimously Recommends Accelerated Approval of Tofersen

marzo 22, 2023 Comentarios desactivados en FDA Committee Unanimously Recommends Accelerated Approval of Tofersen

The FDA Peripheral and Central Nervous System Drugs Advisory Committee voted 9-0 that a reduction in plasma neurofilament light (NfL) concentration is “reasonably likely” to predict clinical benefit of tofersen…

Genetics and My ALS

marzo 17, 2023 Comentarios desactivados en Genetics and My ALS

By Larry Falivena Larry Falivena is a member of The ALS Association’s Board of Trustees and is living with ALS. Today, he is sharing his unique experience with the disease…