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RSS FeedPosted 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 18 Feb 2026
Biosimilar drug poses new test for Medicare price negotiations
12 February 2026 - A drug selected for the latest round of Medicare drug price negotiations stands to get dropped ...
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 12 Feb 2026
Pharma group warns drug price cuts threaten industry investment
10 February 2026 - KPBMA demands postponement, impact assessments, and policy dialogue to protect R&D and health security amid pricing reforms. ...
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 06 Feb 2026
White House debuts drug buying site TrumpRx, with roughly 40 medications
5 February 2026 - Obesity and infertility treatments are among the first crop to appear with discounts on the government-run platform. ...
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 30 Jan 2026
Government of Canada announces the new Chairperson of the Patented Medicine Prices Review Board
29 January 2026 - Today, the Honourable Marjorie Michel, Minister of Health, announced the designation of a new Chairperson for ...
Posted by Michael Wonder on 29 Jan 2026
CMS announces selection of drugs for third cycle of Medicare drug price negotiation program, including first ever Part B drugs
27 January 2026 - The Centers for Medicare & Medicaid Services announced the selection of 15 high cost prescription drugs covered ...
Posted by Michael Wonder on 28 Jan 2026
MHRA takes over Chair of International Access Consortium for 2026
26 January 2026 - The MHRA has formally begun its year as chair of the Access Consortium for 2026, marking ...
Posted by Michael Wonder on 13 Jan 2026
AbbVie and Trump Administration reach agreement to improve access and affordability for Americans
12 January 2026 - AbbVie today announced a voluntary agreement with the Trump administration to further advance access and affordability ...
Posted by Michael Wonder on 28 Dec 2025
Drug makers push back against government’s generic price cut plan
28 December 2025 - Pharma industry warns lower generic prices will curb R&D, health officials cite unchanged pricing since 2012. ...
Posted by Michael Wonder on 24 Dec 2025
Millions need New Year medicines price cut
24 December 2025 - New data reveals Australians are still faced with the tough choice of skipping or rationing medicines—due ...