Blog
RSS FeedPosted 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 12 Jun 2025
EMA 2024 annual report is published
10 June 2025 - The EMA’s annual report 2024 published today gives insights into the Agency’s strategic priorities and contributions ...
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 ...
Posted by Michael Wonder on 03 Apr 2025
Platform clinical trials for the efficient evaluation of multiple treatments
31 March 2025 - For some medical conditions, including conditions without effective treatments, multiple promising but unproven therapies may exist, with ...
Posted by Michael Wonder on 30 Mar 2025
Bristol Myers Squibb receives positive CHMP opinion for peri-operative regimen of neo-adjuvant Opdivo (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo for resectable non-small cell lung cancer in patients with tumour cell PD-L1 expression ≥1%
28 March 2025 - Recommendation based on Phase 3 CheckMate -77T trial showing significant event-free survival improvement when compared to neoadjuvant ...
Posted by Michael Wonder on 08 Mar 2025
FDA’s accelerated approval guidance gets pushback from industry
7 March 2025 - The pharmaceutical industry has some questions regarding the US FDA's recent guidance on its accelerated approval ...
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 17 Feb 2025
Out of pocket getting out of hand - reducing the financial toxicity of rapidly approved drugs
15 February 2025 - In 2023, Teresa was diagnosed with amyotrophic lateral sclerosis. Several months later, her family started a GoFundMe ...
Posted by Michael Wonder on 07 Feb 2025
US FDA approves Emblaveo (aztreonam and avibactam) for the treatment of adults with complicated intra-abdominal infections with limited or no treatment options
7 February 2025 - Emblaveo is the first and only monobactam/β-lactamase inhibitor combination antibiotic therapy approved by the US FDA to ...
Posted by Michael Wonder on 05 Feb 2025
Update on regulatory review of lecanemab for early Alzheimer’s disease in the European Union (July 2024)
26 July 2024 - Eisai and Biogen announced today that the CHMP of the EMA has adopted a negative opinion on ...
Posted by Michael Wonder on 04 Feb 2025
Comparison of clinical evidence submitted to the FDA and EMA for cell and gene therapies
3 February 2025 - Harmonisation in regulatory submissions across agencies may support timelier access to innovative treatments, including cell and gene ...
Posted by Michael Wonder on 01 Feb 2025
Refined interpretation of the Mutual Recognition Agreement between Canada and Switzerland
31 January 2025 - Swissmedic and Health Canada agreed to expand their approach regarding the implementation of the current mutual ...
Posted by Michael Wonder on 28 Jan 2025
Vanda Pharmaceuticals accepts FDA opportunity for a hearing on new drug application for tradipitant in gastroparesis
27 January 2025 - Highlights faulty FDA review. ...
Posted by Michael Wonder on 21 Jan 2025
Drug shortage crisis demands intervention, AMA warns, as patients struggle to secure medicines
20 January 2025 - There are more than 400 medicine shortages, and the country’s leading medical group blames it on ‘ad ...