Blog
RSS FeedPosted by Michael Wonder on 21 Mar 2026
Toward greater transparency at the FDA - now is the time to act
18 March 2026 - The US FDA has generally sought to uphold the highest standards of scientific rigour in its regulation ...
Posted by Michael Wonder on 20 Mar 2026
Political influence ‘a serious problem’ for FDA under Trump, former commissioner says
19 March 2026 - Political influence ‘a serious problem’ for FDA under Trump, former commissioner says. ...
Posted by Michael Wonder on 09 Mar 2026
FDA takes further steps to streamline biosimilar development and make medicines more affordable
9 March 2026 - The US FDA today announced another major step in its initiative to streamline the development of biosimilar ...
Posted by Michael Wonder on 08 Mar 2026
Ottawa should allow all drugs approved in the EU and US to be marketed in Canada
7 March 2026 - The FederalGovernment plans to speed up some drug approvals in Canada by allowing Health Canada to ...
Posted by Michael Wonder on 28 Feb 2026
Opus Genetics announces FDA acceptance of supplemental new drug application for phentolamine ophthalmic solution 0.75% for the treatment of presbyopia
25 February 2026 - Opus Genetics today announced that the US FDA has accepted for review the supplemental new drug ...
Posted by Michael Wonder on 20 Feb 2026
One pivotal trial, the new default option for FDA approval — ending the two-trial dogma
18 February 2026 - This Sounding Board announces a new FDA policy that the default requirement for FDA approvals will be ...
Posted by Michael Wonder on 18 Feb 2026
Moderna announces the US FDA will initiate the review of its investigational seasonal influenza vaccine submission
18 February 2026 - Moderna has received a PDUFA goal date of 5 August 2026. ...
Posted by Michael Wonder on 12 Feb 2026
FDA approves labelling changes to menopausal hormone therapy products
12 February 2026 - The US FDA has approved drug labelling changes to six menopausal hormone therapy products, also known as ...
Posted by Michael Wonder on 10 Feb 2026
FDA intends to take action against non-FDA approved GLP-1 drugs
6 February 2026 - Today, the US FDA is announcing its intent to take decisive steps to restrict GLP-1 active pharmaceutical ...
Posted by Michael Wonder on 03 Feb 2026
EMA starts review of Tavneos, a medicine for rare auto-immune diseases GPA and MPA
30 January 2026 - The EMA’s CHMP has started a review of Tavneos (avacopan), following emerging information that raises questions ...
Posted by Michael Wonder on 31 Jan 2026
Kygevvi (doxecitine and doxribtimine) recommended for approval in the European Union as treatment for thymidine kinase 2 deficiency
30 January 2026 - – UCB today announced that the CHMP of the EMA adopted a positive opinion recommending granting ...
Posted by Michael Wonder on 17 Dec 2025
FDA eliminates major barrier to using real world evidence in drug and device application reviews
15 December 2025 - The US FDA today removed a key limitation on the use of real world evidence used in ...
Posted by Michael Wonder on 14 Dec 2025
Highlights from the 8-11 December 2025 CHMP meeting
12 December 2025 - The EMA’s CHMP recommended seven medicines for approval at its December 2025 meeting. ...
Posted 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 02 Dec 2025
Health Canada and the FDA collaborate on generic drug information sharing initiative
1 December 2025 - Health Canada's Pharmaceutical Drugs Directorate and the US FDA Office of Generic Drugs have created a program ...