Blog
RSS FeedPosted by Michael Wonder on 03 Jul 2024
Approval of newest Alzheimer’s drug will accelerate new era of treatment
2 July 2024 - With the arrival of Lilly’s Kisunla, Alzheimer’s care could become more like treatment of cancer and rheumatoid ...
Posted by Michael Wonder on 01 Jul 2024
FDA opens doors for more treatments for rare diseases through the new START Pilot Program
27 June 2024 - We are at a turning point in understanding the science that is opening doors to rare disease ...
Posted by Michael Wonder on 01 Jul 2024
Real world evidence submissions to the Center for Biologics Evaluation and Research
26 June 2024 - As part of the reauthorisation of the Prescription Drug User Fee Act (PDUFA VII), FDA committed ...
Posted by Michael Wonder on 30 May 2024
FDA use of “proxies” to expedite drug approvals not supported by evidence, analysis finds
28 May 2024 - In the world of drug development, there has been a recent movement to speed clinical trials of ...
Posted by Michael Wonder on 21 May 2024
Federal Trade Commission actions on prescription drugs (2000-2022)
20 May 2024 - The Federal Trade Commission’s oversight role in the pharmaceutical market is critical to the health of ...
Posted by Michael Wonder on 20 May 2024
Overall survival benefits of cancer drugs initially approved by the US FDA on the basis of immature survival data: a retrospective analysis
13 May 2024 - New cancer drugs can be approved by the US FDA on the basis of surrogate endpoints while ...
Posted by Michael Wonder on 27 Apr 2024
A milestone in facilitating the development of safe and effective biosimilars
26 April 2024 - This week, the FDA approved the 50th biosimilar, reflecting the markedly increased availability of biosimilar products—products that ...
Posted by Michael Wonder on 25 Apr 2024
Bashing accelerated approval isn’t supported by the data
24 April 2024 - The FDA’s accelerated approval program aims to speed “approval of drugs that treat serious conditions, and ...
Posted by Michael Wonder on 23 Apr 2024
Associations between surrogate markers and clinical outcomes for non-oncologic chronic disease treatments
22 April 2024 - What is the strength of association between surrogate markers used as primary outcomes in clinical trials ...
Posted by Michael Wonder on 27 Mar 2024
Patient advocates clash over wisdom of ‘approving drugs faster and faster’
26 March 2024 - Over 30 years ago, Gregg Gonsalves and other AIDS activists persuaded Congress to create the accelerated ...
Posted by Michael Wonder on 28 Feb 2024
The FDA isn’t afraid to yank a disappointing drug
26 February 2024 - The FDA is rescinding its approval of a blood cancer treatment from the Swedish firm Oncopeptides, ...
Posted by Michael Wonder on 24 Feb 2024
FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)
23 February 2024 - Today, the FDA announced its final decision to withdraw approval of Pepaxto (melphalan flufenamide), which was ...
Posted by Michael Wonder on 21 Feb 2024
United Therapeutics starts litigation with FDA over rival Liquidia's drug application
21 February 2024 - United Therapeutics said on Wednesday it had filed a case with the US FDA, alleging that ...
Posted by Michael Wonder on 24 Jan 2024
FDA's ISTAND Pilot Program accepts submission of first artificial intelligence based and digital health technology for neuroscience
23 January 2024 - FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research recently accepted a ...
Posted by Michael Wonder on 24 Jan 2024
US FDA seeks 'boxed warning' for CAR-T cancer therapies
22 January 2024 - The US health regulator on Monday asked a host of drug makers, including Gilead Sciences, Johnson ...