explore -WSS

explore

author：knowledge 2025-10-01 05:39:30 - browse：3

The FDA building -- First Opinion coverage from STAT — Adobe

The Food and Drug Administration said Monday that it has deep reservations about NurOwn, an investigational ALS treatment from BrainStorm Cell Therapeutics, citing a lack of evidence that the medicine works and the company’s failure to demonstrate that it can properly manufacture the product.

In documents disclosed ahead of a Wednesday public hearing on NurOwn’s application for approval, the FDA detailed its problems with a clinical trial that missed its primary objective and noted that BrainStorm submitted “grossly deficient” information on how the medicine is made, voicing “major concerns that the available data do not meet the statutory standard of substantial evidence of effectiveness to support” approval.

BrainStorm filed for approval over the FDA’s protest, insisting that NurOwn has demonstrated benefits for a subset of ALS patients with milder disease. That conclusion, based on an after-the-fact analysis of the company’s failed pivotal trial, has proved polarizing among patients and physicians, with some arguing that the FDA should exercise flexibility in light of the irrevocably fatal nature of ALS and others demanding BrainStorm conduct another clinical trial to demonstrate its benefits.

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： The high cost of giving birth even with insurance
Next article： Cholera vaccine supply gets boost as demand surges globally

explore

WSS

Close Medicare's dangerous gaps in addiction treatment coverage

After traumatic brain injury, life support decisions can use more time

Oak Street deal isn't the answer to health care's woes

Dogs on Prozac: What pet anti

Cholera vaccine supply gets boost as demand surges globally

Abbott's new stent may help patients with peripheral artery disease

knowledge

explore

focus

Food as medicine: CMS rules hamper 'prescribing' of fruits, veggies

Bird flu outbreak in cows is latest avian flu curveball

BioMarin wins approval for gene therapy to treat hemophilia A

Getting Alzheimer's drug Leqembi to patients can be a challenge

New air purifier tech could be key to improving indoor air quality

STAT reporters are Pulitzer Prize finalists for investigative reporting

Novavax promises a turnaround & Lilly roils the obesity market

Fertility clinic egg and embryo storage is a disaster

Novavax promises a turnaround & Lilly roils the obesity market

CVS is willing to dump 10% of its Medicare Advantage members

focus

WuXi Biologics beefs up its lobbying operation

MultiPlan and major insurers sued for alleged medical price

Ripples from Flovent's discontinuation is killing children with asthma

WuXi Biologics execs register to lobby as Congress comes for the company

Cherokee Nation medical school graduates its first class

Melinda French Gates resigns from Gates Foundation

explore

focus

focus

hotspot