Blog
RSS FeedPosted by Michael Wonder on 05 Dec 2025
FDA to lower number of trials required for approval of drugs, other medical products
4 December 2025 - Shift could speed development but raises concerns about insufficient evidence on efficacy, safety. ...
Posted by Michael Wonder on 28 Nov 2025
Utilisation of real world evidence in regulatory approvals for multiple myeloma therapies
27 November 2025 - Multiple myeloma is a rare, incurable haematologic malignancy that demands ongoing innovation in treatment approaches given frequent ...
Posted by Michael Wonder on 21 Nov 2025
Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics initiate rolling submission of new drug application to US FDA for zipalertinib for treatment of locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
20 November 2025 - Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics today announced the companies have initiated the rolling submission ...
Posted by Michael Wonder on 15 Nov 2025
FDA’s new plausible mechanism pathway
12 November 2025 - Personalised therapies hold tremendous promise but challenge traditional models of drug and biologic development. ...
Posted by Michael Wonder on 07 Nov 2025
The FDA is a mess, but don’t blame it for everything
6 November 2025 - Biohaven and Uniqure fault agency volatility for setbacks. The reality may be more complicated. ...
Posted by Michael Wonder on 30 Oct 2025
FDA moves to accelerate biosimilar development and lower drug costs
29 October 2025 - The US FDA today announced significant action to make it faster and less costly to develop ...
Posted by Michael Wonder on 27 Oct 2025
Flaws in the FDA’s new priority voucher program
25 October 2025 - A new FDA program is being promoted as a tool to facilitate the development and approval of ...
Posted by Michael Wonder on 23 Sep 2025
FDA takes action to make a treatment available for autism symptoms
22 September 2025 - The US FDA today initiated the approval of leucovorin calcium tablets for patients with cerebral folate ...
Posted by Michael Wonder on 09 Sep 2025
Revisiting the FDA’s accelerated approval pathway
8 September 2025 - After aducanumab’s accelerated approval for Alzheimer's disease, and prompted by long standing concerns regarding the accelerated approval pathway ...
Posted by Michael Wonder on 10 Aug 2025
America’s drug regulator is in turmoil
10 August 2025 - The already fraught oversight of rare disease treatments is becoming politicised. ...
Posted by Michael Wonder on 01 Aug 2025
FDA approves Alhemo as once daily prophylactic treatment to prevent or reduce the frequency of bleeding episodes for adults and children 12 years of age and older with haemophilia A or B without inhibitors
31 July 2025 - FDA approval is based on phase 3 trial data (explorer8), which established the safety and efficacy of ...
Posted by Michael Wonder on 16 Jul 2025
FDA embraces radical transparency by publishing complete response letters
10 July 2025 - The US FDA today published more than 200 decision letters, known as complete response letters. ...
Posted by Michael Wonder on 18 Jun 2025
FDA to issue new Commissioner’s national priority vouchers to companies supporting US national interests
17 June 2025 - The US FDA today announced its Commissioner’s National Priority Voucher program to enhance the health interests of ...
Posted by Michael Wonder on 11 Jun 2025
Priorities for a new FDA
10 June 2025 - Why does it take more than 10 years for a new drug to come to market? Why ...
Posted by Michael Wonder on 21 May 2025
FDA takes steps to enhance state importation programs to help lower prescription drug prices
21 May 2025 - The US FDA is continuing to take steps to help state importation programs provide safe, effective and ...