Blog
RSS FeedPosted by Michael Wonder on 14 May 2025
EMA starts review of Ixchiq (live attenuated chikungunya vaccine)
7 May 2025 - The vaccine must not be used in people 65 years and above while review is underway. ...
Posted by Michael Wonder on 02 Mar 2025
Authorisations of human medicinal products with a new active substance and additional indications 2024
28 February 2025 - 46 human medicinal products with new active substances authorised. ...
Posted by Michael Wonder on 19 Jan 2025
Human medicines in 2024
16 January 2025 - In 2024, EMA recommended 114 medicines for marketing authorisation. ...
Posted by Michael Wonder on 06 Jul 2024
Four decades of orphan drugs and priorities for the future
6 July 2024 - The Orphan Drug Act was enacted in the United States in 1983 in response to growing awareness ...
Posted by Michael Wonder on 03 Jul 2024
The rare paediatric disease voucher program creates new treatments. I have new data to prove it.
2 July 2024 - The FDA’s rare paediatric disease priority review voucher program, which has been providing incentives for lifesaving innovations ...
Posted by Michael Wonder on 31 May 2024
Annual report highlights progress in science, medicines and health in 2023
30 May 2024 - EMA’s annual report 2023 published today details the Agency’s contributions to public and animal health in the ...
Posted by Michael Wonder on 07 May 2024
Clinical benefit and regulatory outcomes of cancer drugs receiving accelerated approval
7 May 2024 - In this cohort study of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did ...
Posted by Michael Wonder on 16 Jan 2024
Human medicines: highlights of 2023
16 January 2024 - In 2023, EMA recommended 77 medicines for marketing authorisation. ...
Posted by Michael Wonder on 21 Nov 2023
FDA faces reckoning over short-cut drug approvals
21 November 2023 - Most people probably assume that all prescription drugs on the US market have been proven effective in ...
Posted by Michael Wonder on 31 Jan 2023
FDA may not always require post-approval trials to be enrolled before accelerated approvals
30 January 2023 - A FDa official on Monday gave more clues for how the agency plans to wield new authority ...
Posted by Michael Wonder on 25 Jan 2023
The 4 biggest questions about the FDA’s forthcoming changes to accelerated approvals
25 January 2023 - Congress just boosted the FDA’s authority over the post-market clinical trials that are a condition of ...
Posted by Michael Wonder on 18 Jan 2023
FDA’s breakthrough program: faster drug OKs without sacrificing safety
18 January 2023 - A FDA program markedly cut the time and cost of bringing to market new drugs, without ...
Posted by Michael Wonder on 11 Jan 2023
Prescription drug policy, 2022 and 2023: the year in review and the year ahead
9 January 2023 - This past year featured many significant developments in the prescription drug policy area, most notably the passage ...
Posted by Michael Wonder on 21 Nov 2022
FDA cancer chief wants quicker ways to pull failed drugs
17 November 2022 - Makena highlights need to make system more nimble. ...
Posted by Michael Wonder on 15 Oct 2022
Gottlieb, McClellan push for FDA regulatory reforms
14 October 2022 - The decision by law makers to drop regulatory reforms of dietary supplements, cosmetics and diagnostic tests from ...