Nasdaq

FDA Accelerated Approval of Tofersen Highlights Importance of Blood Neurofilament Light Chain as Surrogate Endpoint in Neurology Therapeutic Trials

Blood-based measurement of neurofilament light chain (NfL) provides compelling evidence to support an accelerated drug approval by the FDA. The decision has positive implications for NfL blood testing ...
Seeking Alpha

Ionis And Biogen: Tofersen PDUFA Looms - Positive Outcome May Kick Off Bull Run For Both Stocks

Ionis and Biogen have been partnering on antisense drug development for a decade. The two companies won approval for $1.8bn (in 2022) Spinraza, indicated for Spinal Muscular Atrophy. Tofersen, ...

New ALS drug stabilizes decline with a trend toward improved strength and mobility for some

Historically, people with amyotrophic lateral sclerosis (ALS) experience a relentless decline in neurological function that ...
MM&M

FDA approves Biogen and Ionis’ Tofersen for rare genetic form of ALS

The Food and Drug Administration approved Tofersen, an investigational drug developed by Biogen and Ionis Pharmaceuticals, to treat a rare genetic form of amyotrophic lateral sclerosis (ALS) Tuesday ...
Healthcare Dive

FDA approves new ALS medicine in precedent-setting decision

The Food and Drug Administration has conditionally approved a new ALS medicine in a decision likely to influence how other experimental treatments for the nerve-destroying disease are tested and ...
ALZFORUM

FDA Grants Accelerated Approval for Tofersen

The U.S. Food and Drug Administration has approved tofersen for the treatment of ALS. Developed originally by Ionis Pharmaceuticals and evaluated in clinical trials by Biogen, the antisense ...
WHNT

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

“For more than a decade, Biogen has been steadfast in our commitment to pursuing treatments for ALS, and I want to thank the scientists as well as the entire ALS community who have all worked ...
MedPage Today on MSN

Long-term tofersen use may slow ALS progression, 3-year data suggest

Early initiation of tofersen (Qalsody) was associated with a numerically slower decline in people with SOD1 amyotrophic ...
Healthline

ALS: FDA Approves Drug Tofersen for Rare Form of Disease

Share on Pinterest Researchers are hopeful that a new drug can help treat the symptoms of a rare type of ALS. herraez/Getty Images The Food and Drug Administration (FDA) has approved the drug toferson ...
Healio

FDA advisory committee votes for potential accelerated approval of tofersen for SOD1-ALS

Please provide your email address to receive an email when new articles are posted on . The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously that tofersen, an ...

New drug may slow progression of ALS in small group of patients: Study

A new drug may slow progression of -- and even reverse -- symptoms of a rare form of amyotrophic lateral sclerosis, or ALS, a ...
Business Wire

FDA Accelerated Approval of Tofersen Highlights Importance of Blood Neurofilament Light Chain as Surrogate Endpoint in Neurology Therapeutic Trials

BILLERICA, Mass.--(BUSINESS WIRE)--Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery and breakthrough diagnostics through ultrasensitive biomarker detection, today announced ...