Tag: FDA approval

Donald Trump

Donald Trump bragged that “right-to-try” has saved thousands of lives. It hasn’t.

Former President Donald Trump bragged in his acceptance speech at the Republican National Convention that "right-to-try" had saved "thousands of lives"? What's the real story? (Hint: Nowhere near that.)

/ July 22, 2024

FDA Advisory Committee Recommends approval of new Alzheimer’s drug Donanemab

If approved, donanemab would be the third FDA approved disease-modifying beta-amyloid treatment for Alzheimer’s disease.

/ June 23, 2024
Macular degeneration

Pegcetacoplan (Syfovre™) for macular degeneration: an update

SBM's guest contributor and ophthalmologist, Dr. David Weinberg, provides an update on the phase 3 trials of pegcetacoplan for macular degeneration. The results are still disappointing.

/ January 11, 2024

FDA Approves Controversial ALS Drug – Relyvrio

A close look a the FDA approval of Relyvrio.

/ October 5, 2022
Alzheimer's Disease

No evidence, no problem: A closer look at the aducanumab approval

Why did the FDA approve aducanumab, a drug that hasn't been shown to work?

/ June 10, 2021

FTC settles false advertising suit against low-level light therapy marketer with $22 million judgment

Per a settlement with the FTC, the marketers of Willow Curve, a low-level light therapy device costing hundreds of dollars, will have to stop making deceptive claims that the device treats chronic, severe pain and associated inflammation. Any health claims made for the device must be supported by "competent and reliable scientific evidence".

/ July 2, 2020

The illusions of “right to try” laws

[Ed. Note: For additional commentary on why “right-to-try” laws are such a bad idea, see “Right to try” laws and Dallas Buyers’ Club: Great movie, terrible for patients and terrible policy and The false hope of “right-to-try” metastasizes to Michigan.] There is nothing like a touching anecdote to spur a politician into action. And those who want to try investigational drugs outside...

/ March 6, 2014

Bogus Electrodermal Testing Devices and the Failure of Regulators to Act

Electrodermal testing is a bogus procedure where measurements of skin conductance with a biofeedback device are entered into a computer to diagnose nonexistent health problems and “energy imbalances” and to recommend treatments for them, often involving the sale of homeopathic remedies and other useless products. It falls under the general category of EAV (Electro Acupuncture of Voll). The history and variants of...

/ March 5, 2013

Electrodermal Testing Part II: Legal and Regulatory Aspects

Last week I described electrodermal testing. I’m sure many readers thought, “There oughta be a law against that.” Well, there are laws. Unfortunately, having laws and enforcing them are two different things. Some of these devices are not approved at all. Most have received 501(k) approval from the FDA as biofeedback devices so similar to previous devices that they do not require...

/ July 12, 2011