Blog
RSS FeedPosted by Michael Wonder on 16 Mar 2026
EMA proposes new paper on proof of concept studies for paediatric oncology drugs
13 March 2026 - The EMA has released a concept paper proposing a future reflection paper on the development of ...
Posted by Michael Wonder on 24 Feb 2026
FDA launches framework for accelerating development of individualised therapies for ultra-rare diseases
23 February 2026 - The U.S. FDA today issued draft guidance for sponsors seeking approval for targeted individualised therapies by ...
Posted by Michael Wonder on 23 Jan 2026
Minimal residual disease and complete response in multiple myeloma: use as outcomes to support accelerated approval
20 January 2026 - This guidance provides recommendations to sponsors about using minimal residual disease and complete response in multiple myeloma ...
Posted by Michael Wonder on 16 Jan 2026
Guiding principles of good AI practice in drug development
14 January 2026 - The CDER and CBER have collaborated with the EMA to develop 10 guiding principles that industry ...
Posted by Michael Wonder on 03 Mar 2025
Supporting the development of drugs for rare diseases - the importance of regulatory transparency
1 March 2025 - Transparency regarding the information submitted to the FDA and the agency’s decision making could have far-reaching ...
Posted by Michael Wonder on 19 Jun 2024
How AI is revolutionising drug development
17 June 2024 - In high-tech labs, workers are generating data to train AI algorithms to design better medicine, faster. But ...
Posted by Michael Wonder on 13 Feb 2024
The threat of fungal infections is growing. Why is it so hard to make new drugs?
11 February 2024 - Last summer, the FDA denied an application for a new anti-fungal drug called olorofim, sending it back ...
Posted by Michael Wonder on 07 Feb 2024
FDA and EMA launch parallel scientific advice pilot program for complex generics
7 February 2024 - CDER’s Office of Generic Drugs and the EMA launched a voluntary pilot program to facilitate concurrent discussions ...
Posted by Michael Wonder on 04 Feb 2024
Addressing the challenge of common chronic diseases — a view from the FDA
3 February 2024 - Of the 10 most common causes of death in the United States, 7 are chronic diseases: ...
Posted by Michael Wonder on 12 Nov 2023
MedChem a game changer in identifying lifesaving new drugs
8 November 2023 - The Australian Government is ensuring the next generation of lifesaving drugs and world-class medical treatments can be ...
Posted by Michael Wonder on 07 Nov 2023
Germany, Belgium and France among those hit hardest as Commission’s Pharma-legislation proposals risk Europe losing a third of its share of global R&D by 2040
6 November 2023 - The European Federation of Pharmaceutical Industries and Associations (EFPIA) is publishing new research which assesses the ...
Posted by Michael Wonder on 07 Nov 2023
NICE launches refreshed support service for life sciences industry
6 November 2023 - NICE has today launched its refreshed support service for the life sciences sector, NICE Advice. ...
Posted by Michael Wonder on 29 Sep 2023
FDA launches pilot program to help further accelerate development of rare disease therapies
29 September 2023 - Today, the US FDA is taking steps to help further accelerate the development of novel drug and ...
Posted by Michael Wonder on 08 Aug 2023
UKHSA unveils VDEC in ‘step change’ for UK’s growing vaccine capabilities
7 August 2023 - Vaccine Development and Evaluation Centre to be at forefront of UK’s ability to research and develop vaccines ...
Posted by Michael Wonder on 23 Jul 2023
How a drug maker profited by slow walking a promising HIV therapy
22 July 2023 - Gilead delayed a new version of a drug, allowing it to extend the patent life of a ...