Blog
RSS FeedPosted by Michael Wonder on 22 Jun 2021
FDA 'may require' post-marketing studies to analyse long-term effects of breast cancer drugs
21 June 2021 - The US FDA "may require” or seek agreement from sponsors to conduct post-marketing studies to analyse ...
Posted by Michael Wonder on 20 Jun 2021
US plays catch-up with Europe over biosimilar patents
17 June 2021 - Moves to ease market access for generic drug makers are gaining momentum. ...
Posted by Michael Wonder on 18 Jun 2021
3D bioprinting can help end organ transplant waitlists — if the FDA stops delaying
18 June 2021 - Right now, more than 100,000 Americans are waiting for organ transplants. Due to a lack of ...
Posted by Michael Wonder on 18 Jun 2021
Manchin wants Biden to oust FDA Chief over controversial Alzheimer’s drug approval
17 June 2021 - After some of the FDA’s outside advisors quit in outrage after the agency approved a controversial new ...
Posted by Michael Wonder on 17 Jun 2021
Furore rages over FDA approval of controversial Alzheimer’s drug
17 June 2021 - Critics attack the agency’s action as reckless, but defenders say patients will benefit. ...
Posted by Michael Wonder on 17 Jun 2021
The FDA is in desperate need of some soul-searching
17 June 2021 - Ordinarily, the approval of a new drug for a dreaded disease affecting millions of Americans would be ...
Posted by Michael Wonder on 16 Jun 2021
‘A litany of flaws’: advocacy group urges HHS to boot FDA officials over Alzheimer’s drug approval
16 June 2021 - Reacting to the controversial approval of the Biogen Alzheimer’s drug, a leading advocacy group is urging ...
Posted by Michael Wonder on 15 Jun 2021
6 ways the FDA’s approval of Aduhelm does more harm than good
15 June 2021 - Like many people, I was shocked when the FDA ignored the advice of its neurological drugs ...
Posted by Michael Wonder on 14 Jun 2021
The FDA still lacks a permanent chief, despite pressing, weighty problems
12 June 2021 - With the pandemic easing, the federal agency’s long-term agenda for drug approvals or new issues is languishing ...
Posted by Michael Wonder on 11 Jun 2021
Third member of prestigious FDA panel resigns over approval of Biogen's Alzheimer's drug
10 June 2021 - A third member of a key FDA advisory panel has resigned over the agency's controversial decision to ...
Posted by Michael Wonder on 10 Jun 2021
America’s approval of an Alzheimer’s drug is premature
12 June 2021 - It may offer false hope and divert resources from more promising therapies. ...
Posted by Michael Wonder on 10 Jun 2021
Two members of U.S. FDA advisory panel resign over Alzheimer's drug approval
9 June 2021 - Two members of a panel of outside advisors to the U.S. FDA have resigned in protest ...
Posted by Michael Wonder on 07 Jun 2021
Innovative regenerative medicine therapies – patient safety comes first
3 June 2021 - The U.S. FDA continues to facilitate the development and availability of innovative medical products, such as regenerative ...
Posted by Michael Wonder on 06 Jun 2021
FDA’s decision on Biogen Alzheimer’s drug will be a watershed moment for the agency — and the biotech industry
4 June 2021 - In the coming days the FDA will make one of its most important — and controversial — ...
Posted by Michael Wonder on 05 Jun 2021
Alzheimer’s drug poses a dilemma for the FDA
5 June 2021 - If the agency approves it, aducanumab would be the first new Alzheimer’s treatment since 2003. ...