hotspot -WSS

hotspot

author：explore 2025-09-01 15:20:28 - browse：13212

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

A panel of independent advisers to the Food and Drug Administration voted overwhelmingly against a polarizing potential treatment for ALS on Wednesday, concluding that the medicine’s messy supporting data did not meet the standard for approval.

After a day-long meeting that included impassioned testimony from ALS patients, the agency’s expert advisers voted 17-1 with one abstention that the case for NurOwn, a treatment from BrainStorm Cell Therapeutics, was based too heavily on convoluted clinical trial results and compelling but unreliable anecdotal evidence.

“Patients and families need hope, but providing false hope can be ethically problematic,” said panelist Lisa Lee, a bioethicist at Virginia Tech. “False hope is provided when the probability of a positive outcome is overestimated, and I think that seems to be the case here.”

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

Subscribe Log In

Previous article： How one medical school became remarkably diverse
Next article： How to use technology to prevent future drug shortages

knowledge

WSS

Twitch streamer Kai Cenat speaks out for 1st time since causing mayhem with Union Square giveaway

Novo: Oral version of Ozempic leads to 15% weight loss

Sea level rise could wash away turtle breeding grounds around the world, researchers say

Science's Marcia McNutt, trailblazer for women, encounters sexism scandal

How to use technology to prevent future drug shortages

Over 1,300 arrested in France in 4th night of protests over fatal police shooting of teen Nahel M.

hotspot

hotspot

knowledge

Alkermes shareholders re

Senate panel passes drug pricing bills, but drops one PBM reform

Alkermes shareholders re

American woman, child freed after being kidnapped in Haiti last month

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

Novo: Oral version of Ozempic leads to 15% weight loss

Anesthesiologist group: stop taking Ozempic before surgery

Timeline: Key moments in fight for gay rights

FDA approval of Sarepta Duchenne genetic therapy gives me hope

Biden administration plans revamp of organ transplant system

knowledge

Twitch streamer Kai Cenat speaks out for 1st time since causing mayhem with Union Square giveaway

For Cytokinetics, FDA rejection of heart drug would help, not hinder

Wegovy trial has doctors encouraged over new possibilities

Listen: Merck v. USA, the best of ASCO, and Leqembi at the FDA

Drastic changes should bring profitability, startup health insurers say

Reanimated hearts work just as well for transplants, study finds

hotspot

knowledge

explore

focus