Blog
RSS FeedPosted by Michael Wonder on 13 Jul 2021
Biden in standoff with Democratic senators over who should lead FDA
13 July 2021 - Nearly six months into a presidency fully engulfed in a battle against a global pandemic, President Joe ...
Posted by Michael Wonder on 13 Jul 2021
Powerful House Democrats demand documents from Biogen about co-ordination with FDA on new Alzheimer’s drug
12 July 2021 - Two powerful House Democrats on Monday demanded documents from Biogen about the approval process, marketing, and ...
Posted by Michael Wonder on 12 Jul 2021
FDA’s expansive Alzheimer’s drug approval surprised even top agency officials
9 July 2021 - The FDA’s contentious decision to approve a new Alzheimer’s drug for every single patient with the ...
Posted by Michael Wonder on 10 Jul 2021
FDA seeks to probe talks between staff and Biogen on Alzheimer’s drug
9 July 2021 - The FDA’s chief is taking the highly unusual step of asking for a federal investigation of doctors ...
Posted by Michael Wonder on 08 Jul 2021
In a reversal, FDA calls for limits on who gets Alzheimer’s drug
8 July 2021 - The agency faced criticism for approving Aduhelm for all Alzheimer’s patients. The new label recommends that the ...
Posted by Michael Wonder on 06 Jul 2021
Cures for many rare diseases might already exist. Why aren’t we using them?
5 July 2021 - Scientists may have already developed cures for cystic fibrosis, muscular dystrophy, and rare cancers—they just don't realise ...
Posted by Michael Wonder on 06 Jul 2021
Novartis tries to rescue stalled inclisiran filing with FDA
6 July 2021 - Novartis has tried to get its marketing application for high cholesterol therapy inclisiran in the US ...
Posted by Michael Wonder on 06 Jul 2021
The controversial approval of an Alzheimer’s drug reignites the battle over the underlying cause of the disease
6 July 2021 - A new treatment targets amyloid clumps in the brain, but researchers have long debated whether that will ...
Posted by Michael Wonder on 05 Jul 2021
It’s time for the FDA to fully approve the mRNA vaccines
1 July 2021 - Here’s a paradox: a new drug for Alzheimer’s disease, aducanumab, gets approved by the FDA through an ...
Posted by Michael Wonder on 01 Jul 2021
Calls grow for an investigation into FDA approval of Biogen’s Alzheimer’s drug
30 June 2021 - Former health secretary Donna Shalala called for a federal investigation into the FDA’s polarising approval of ...
Posted by Michael Wonder on 29 Jun 2021
Inside ‘Project Onyx’: how Biogen used an FDA back channel to win approval of its polarising Alzheimer’s drug
29 June 2021 - It was perhaps the most contentious drug approval in decades, shocking drug company executives, insurance companies, ...
Posted by Michael Wonder on 24 Jun 2021
ALS association wants more commitment from the FDA
24 June 2021 - In a response letter to the ALS Association, the U.S. FDA has recognised the unmet therapeutic ...
Posted by Michael Wonder on 23 Jun 2021
FDA chief under fire over Alzheimer’s drug decision
22 June 2021 - US regulator’s approval of controversial treatment shows it is too close to Big Pharma, say critics. ...
Posted by Michael Wonder on 23 Jun 2021
Aducanumab (Aduhelm) information
22 June 2021 - The FDA has posted the CDER’s Office of Neurology’s Summary Review Memorandum describing the agency’s extensive ...
Posted by Michael Wonder on 22 Jun 2021
FDA approved Biogen Alzheimer’s drug despite some staff concerns
22 June 2021 - The agency has faced criticism for approving the drug, Aduhelm, without clear proof it works. ...