leisure time -WSS

leisure time

author：fashion 2025-09-30 18:58:49 - 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： Psychedelics group wrestles with new pharma identity
Next article： What will Novo Nordisk's VC do with its influx of cash?

hotspot

Wikipedia

WSS

With clinical trial data readouts, here's how to spot spin

As biotech industry slumps, bioscience job market is upside down

UnitedHealth has 90,000 doctors — 10% of all physicians in U.S.

U.K. Biobank has 500,000 peoples' genome sequences available

Medicare innovation center doesn’t save money, experts say

How to pay for weight loss drugs and save Medicare

knowledge

leisure time

knowledge

Trump demands the U.S. pay no more for drugs than other countries … again

Will an HIV vaccine ever be a reality?

Indiana Supreme Court upholds abortion ban, says state constitution gives only limited protections

The stability of $0 premiums in Medicare Advantage

Sports medicine is finally prioritizing gender equality

IVG is promising — but it won’t replace IVF quite yet

Activists slam private health insurers over coverage restrictions

What we owe ALS patients — and why one company fell short

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

Stop Congress from blocking public access to science

explore

BIO selects John Crowley as new CEO

Lawsuit highlights wrinkle for disputes over surprise medical bills

European officials brace for rough respiratory virus season

BIO selects John Crowley as new CEO

FDA sees ‘potential systemic bias’ in Amgen’s KRAS drug trial

WHO recommends second malaria vaccine

hotspot

Wikipedia

focus

focus