Blog
RSS FeedPosted by Michael Wonder on 01 Jun 2022
Summary of US FDA chimeric antigen receptor T-cell biologics license application approvals from a statistical perspective
25 May 2022 - The approval of tisagenlecleucel and axicabtagene ciloleucel in 2017 marked a milestone in the development of oncology ...
Posted by Michael Wonder on 01 Jun 2022
FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns
1 June 2022 - Possible increased risk of death outweighs the benefits. ...
Posted by Michael Wonder on 30 May 2022
Why won’t the FDA let doctors prescribe fluvoxamine for COVID?
30 May 2022 - Trials show it keeps patients from getting sicker, but the agency won’t approve its emergency use. ...
Posted by Michael Wonder on 29 May 2022
Accelerated approval: unfulfilled promises for FDA’s expedited review program
27 May 2022 - As practicing physicians, approval by the U.S. FDA reassures us that the treatments we prescribe our patients ...
Posted by Michael Wonder on 27 May 2022
Key Senate committee proposes a council to ensure FDA better coordinates on accelerated approvals
27 May 2022 - The Senate is taking pains to avoid another Aduhelm controversy. ...
Posted by Michael Wonder on 27 May 2022
Biden has confidence in the FDA and its commissioner, White House says
27 May 2022 - U.S. President Joe Biden has confidence in the U.S. FDA and its commissioner Robert Califf, White House ...
Posted by Michael Wonder on 22 May 2022
Patients deserve immediate access to FDA approved innovations — not bureaucratic restrictions
21 May 2022 - Innovation is the lifeblood that has made America the most economically successful nation in the modern era. ...
Posted by Michael Wonder on 18 May 2022
FDA, EMA officials discuss impediments to cell and gene therapies
17 May 2022 - The US FDA's top biologics regulator said the use of a “playbook” or platform approach ...
Posted by Michael Wonder on 17 May 2022
Understanding ‘evergreening’: making minor modifications of existing medications to extend protections
17 May 2022 - Recent studies have examined strategic behaviours in the pharmaceutical industry that extend patent and regulatory protection, known ...
Posted by Michael Wonder on 13 May 2022
Will the FDA change how it vets drugs following the Alzheimer's debacle?
13 May 2022 - The accelerated approval of aducanumab has triggered US law makers to push for more oversight from the ...
Posted by Michael Wonder on 10 May 2022
Exit Aduhelm, enter lecanemab. Biogen and Eisai have another go
10 May 2022 - Here we go again. With Aduhelm largely sidelined, Biogen and Eisai are hoping for a better ...
Posted by Michael Wonder on 10 May 2022
FDA launches new Accelerating Rare disease Cures (ARC) program
10 May 2022 - FDA’s Center for Drug Evaluation and Research (CDER) is pleased to announce the launch of the new ...
Posted by Michael Wonder on 08 May 2022
Wearable technology promises to revolutionise health care
5 May 2022 - Do not let bureaucracy delay matters. ...
Posted by Michael Wonder on 07 May 2022
FDA limits use of Janssen COVID-19 vaccine to certain individuals
5 May 2022 - Today, the U.S. FDA has limited the authorised use of the Janssen COVID-19 Vaccine to individuals ...
Posted by Michael Wonder on 06 May 2022
Congress moves toward reforming FDA accelerated approvals, but with pharma friendly concessions
4 May 2022 - House lawmakers are moving a little closer toward cracking down on drugmakers that game the FDA’s ...