leisure time -WSS

leisure time

author：Wikipedia 2025-09-27 16:46:21 - browse：7

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： Virginia high school admissions case could be legal follow
Next article： Maui wildfire now ranks as the fifth

explore

WSS

'Stay indoors': Escaped wild animal on the loose in Berlin prompts urgent citywide search

DeSantis talks Trump, trans issues and 'what wokeness is'

Sweeping indictment could be Trump's biggest legal challenge yet: ANALYSIS

Novo Nordisk touts Wegovy study, but still struggling with supply

Sweeping indictment could be Trump's biggest legal challenge yet: ANALYSIS

Megan Rapinoe shares emotional post following US Women's World Cup exit

knowledge

leisure time

Wikipedia

Guidelines to prevent youth baseball injuries need more muscle

Public funding for King Charles III and royals has been recalculated due to windfarm deal profits

Medical records are filled with copy

Senators push IRS to launch nonprofit hospital probe

As demand for Covid shots wanes, Moderna seeks its next success

Wildfires rage amid heat wave in Greece, prompting evacuations and call for European support

Duchenne breakthrough therapy leaves behind pioneering families

Surge in Apellis stock fueled by confidence in safety of its eye drug

Alkermes shareholders re

Senators push IRS to launch nonprofit hospital probe

Wikipedia

Texas Department of Public Safety speaks out on migrant abuse allegations

Mark Cuban is blaming the wrong people for high drug costs

Schizophrenia gene found to be linked to cells' energy dysfunction

Bird flu researchers hone in on Finland’s mink farms

Maui wildfire now ranks as the fifth

Patients, digital health players weigh in on FTC's data privacy plan

leisure time

explore

Wikipedia

focus