FDA Approves Qalsody for Rare Form of ALS
WEDNESDAY, April 26, 2023– The U.S. Food and Drug Administration on Tuesday approved a new drug for people who have a rare, inherited type of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig ' s disease.
The medication, toferson... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - April 26, 2023 Category: General Medicine Source Type: news
FDA Approves Drug for Rare Form of ALS
WEDNESDAY, April 26, 2023 – The U.S. Food and Drug Administration on Tuesday approved a new drug for people who have a rare, inherited type of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig ' s disease.
The medication, toferson... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - April 26, 2023 Category: General Medicine Source Type: news
FDA approves new drug for rare form of ALS
The U.S. Food and Drug Administration approved a new drug Tuesday to treat a rare form of amyotrophic lateral sclerosis, or ALS. The drug Qalsody (tofersen) is expected to help people with a very specific mutation, SOD1, which applies to only 2% of the ALS population. In a statement, the FDA said…#als #sod1 #fda #sod1als #rna #nfl #jamesberry #abcnews #mgh #biogen (Source: Reuters: Health)
Source: Reuters: Health - April 26, 2023 Category: Consumer Health News Source Type: news
FDA Grants Accelerated Approval for Qalsody (tofersen) for the Treatment of Amyotrophic Lateral Sclerosis Associated with a Mutation in the SOD1 Gene
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 treatment of amyotrophic lateral sclerosis... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 25, 2023 Category: Drugs & Pharmacology Source Type: news
FDA Approves Drug to Treat Rare Form of ALS
Biogen Inc.’s drug for a rare form of amyotrophic lateral sclerosis was approved by U.S. regulators, marking the first clearance of a treatment targeting a specific genetic cause of the incurable paralysis disease.
The Food and Drug Administration granted clearance for the drug, called Qalsody, through an accelerated approval pathway, meaning Biogen must conduct more research to establish its benefits for it to remain on the market. The approval was disclosed on the agency’s website Tuesday.
ALS, sometimes called Lou Gehrig’s disease, destroys nerve cells that control voluntary muscle movement, including ...
Source: TIME: Health - April 25, 2023 Category: Consumer Health News Authors: Fiona Rutherford and Robert Langreth/Bloomberg Tags: Uncategorized bloomberg wire Drugs healthscienceclimate Source Type: news
FDA Approves Biogen ’s Drug for Rare Form of ALS
The drug, which will be sold as Qalsody by the pharmaceutical company Biogen, targets a genetic cause of a devastating neurological illness. (Source: NYT Health)
Source: NYT Health - April 25, 2023 Category: Consumer Health News Authors: Rebecca Robbins Tags: Drugs (Pharmaceuticals) Genetics and Heredity Amyotrophic Lateral Sclerosis Biogen Inc Food and Drug Administration Source Type: news
Drug for Rare Form of ALS Earns FDA Nod
(MedPage Today) -- The FDA granted accelerated approval to tofersen (Qalsody) for amyotrophic lateral sclerosis (ALS) patients with mutations in the SOD1 gene, the agency announced on Tuesday.
The drug was cleared under the accelerated approval... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - April 25, 2023 Category: American Health Source Type: news
FDA approves treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene
FDA approved Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene (SOD1-ALS). Qalsody is an antisense oligonucleotide that targets SOD1 mRNA to reduce the synthesis of SOD1 protein. The approval was based o (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 25, 2023 Category: Drugs & Pharmacology Authors: FDA Source Type: news
BrainStorm Cell Therapeutics Announces FDA Advisory Committee Meeting to Review Biologics License Application for NurOwn(R) for the Treatment of ALS
Conference call and webcast at 8:00 a.m. ET
NEW YORK, March 27, 2023 -- (Healthcare Sales & Marketing Network) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, toda... Regenerative Medicine, Neurology, FDA BrainStorm Cell Therapeutics, NurOwn, amyotrophic lateral sclerosis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 27, 2023 Category: Pharmaceuticals Source Type: news
FDA Panel Supports Tofersen for Rare Genetic ALS
(MedPage Today) -- A panel of FDA advisors voted unanimously that plasma neurofilament light chain (NfL), a biomarker of neurodegeneration, is a reasonable surrogate endpoint in amyotrophic lateral sclerosis (ALS) associated with a mutation in... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - March 23, 2023 Category: American Health Source Type: news
Biogen ALS drug considered not effective by FDA advisory panel
Biogen Inc. BIIB, received a setback late Wednesday after a Food and Drug Administration advisory committee said the biotech drug maker’s proposed amyotrophic lateral sclerosis, or ALS, treatment did not show it was effective. On Wednesday, the FDA’s Peripheral and Central Nervous System Drugs…#biogeninc #als #fda #toferson #biogen (Source: Reuters: Health)
Source: Reuters: Health - March 23, 2023 Category: Consumer Health News Source Type: news
FDA advisors vote against effectiveness of Biogen's ALS drug for rare and aggressive form of the disease
The Food and Drug Administration's independent panel of advisors on Wednesday voted against the effectiveness of Biogen's investigational ALS drug for a rare and aggressive form of the disease. The drug tofersen was developed to treat a rare genetic form of amyotrophic lateral sclerosis, or ALS.…#biogen #als #lianaapostolova #michellemielke #fda #lougehrig #sod1 #nfl #sod1als #davidweisman (Source: Reuters: Health)
Source: Reuters: Health - March 22, 2023 Category: Consumer Health News Source Type: news
FDA advisors reject Biogen's ALS drug for rare and aggressive form of the disease
The Food and Drug Administration's independent panel of advisors on Wednesday declined to endorse accelerated approval of Biogen's investigational ALS drug for a rare and aggressive form of the disease. The drug tofersen was developed to treat a rare genetic form of amyotrophic lateral sclerosis,…#biogen #als #lianaapostolova #michellemielke #fda #lougehrig #sod1 #nfl #sod1als #davidweisman (Source: Reuters: Health)
Source: Reuters: Health - March 22, 2023 Category: Consumer Health News Source Type: news
Investigational ALS Drug May Have Clinical Benefit, FDA Staff Says
(MedPage Today) -- Tofersen, an investigational antisense drug developed to treat amyotrophic lateral sclerosis (ALS) associated with a mutation in the SOD1 gene (SOD1-ALS), may have clinical benefit, FDA reviewers indicated in briefing documents... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - March 21, 2023 Category: American Health Source Type: news
DNA treatment could delay paralysis that strikes nearly all patients with ALS
In virtually all persons with amyotrophic lateral sclerosis (ALS) and in up to half of all cases of Alzheimer's disease (AD) and frontotemporal dementia, a protein called TDP-43 is lost from its normal location in the nucleus of the cell. In turn, this triggers the loss of stathmin-2, a protein crucial to regeneration of neurons and the maintenance of their connections to muscle fibers, essential to contraction and movement. (Source: World Pharma News)
Source: World Pharma News - March 16, 2023 Category: Pharmaceuticals Tags: Featured Research Research and Development Source Type: news
