Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 03 Dec 2025
Australia in talks with US over Trump demands to pay more for medicine
2 December 2025 - Australia is talking to the Trump administration and global drug companies about the United States’ push ...
Posted by Michael Wonder on 03 Dec 2025
New hope for rare cancer patients as first immunotherapy treatment subsidised
3 December 2025 - An immunotherapy treatment for a potentially disfiguring form of head and neck cancer has been added to ...
Posted by Michael Wonder on 03 Dec 2025
Anzupgo (delgocitinib cream) now available in Canada for adult patients living with moderate to severe chronic hand eczema
2 December 2025 - Leo Pharma is pleased to announce the availability of Anzupgo (delgocitinib cream) across Canada for adults ...
Posted by Michael Wonder on 03 Dec 2025
Ionis receives US FDA breakthrough therapy designation for zilganersen for Alexander disease
2 December 2025 - On track to submit new drug application in Q1, 2026. ...
Posted by Michael Wonder on 03 Dec 2025
Sangamo Therapeutics receives US FDA fast track designation for ST-503 for the treatment of small fibre neuropathy
2 December 2025 - Sangamo Therapeutics today announced that the US FDA has granted fast track designation to ST-503, an investigational ...
Posted by Michael Wonder on 03 Dec 2025
Arrowhead Pharmaceuticals receives FDA breakthrough therapy designation for plozasiran in severe hypertriglyceridaemia
2 December 2025 - Arrowhead Pharmaceuticals today announced that the US FDA has granted breakthrough therapy designation to investigational plozasiran as ...
Posted by Michael Wonder on 02 Dec 2025
Baxdrostat new drug application accepted under FDA priority review in the US for patients with hard to control hypertension
2 December 2025 - Submission based on positive BaxHTN Phase 3 trial results which demonstrated statistically significant and clinically meaningful reduction ...
Posted by Michael Wonder on 02 Dec 2025
Korea eases path to breakthrough drugs with flexible ICER rules
1 December 2025 - The Government has unveiled a large-scale overhaul of the health insurance drug pricing system, proposing flexible ...
Posted by Michael Wonder on 02 Dec 2025
MannKind announces US FDA accepts for review its supplemental new drug application of Furoscix ReadyFlow Auto-injector for the treatment of oedema in adults with chronic heart failure or chronic kidney disease
1 December 2025 - MannKind Corporation today announced that the US FDA has accepted the sNDA seeking approval for Furoscix ReadyFlow ...
Posted by Michael Wonder on 02 Dec 2025
GSK’s Jemperli now standard in endometrial cancer as reimbursement expands to first-line therapy
1 December 2025 - GSK’s Jemperli has secured its position as a standard treatment option in endometrial cancer following Korea’s ...
Posted by Michael Wonder on 02 Dec 2025
Solid Biosciences receives FDA rare paediatric disease designation for SGT-212 dual route of administration gene therapy for Friedreich’s ataxia
1 December 2025 - Solid Biosciences today announced that it received rare paediatric disease designation from the US FDA for SGT-212, ...
Posted by Michael Wonder on 02 Dec 2025
Samsung Bioepis announces launch of denosumab biosimilars, Obodence and Xbryk in Europe
1 December 2025 - Samsung Bioepis today announced the launch of Obodence (60 mg pre-filled syringe) and Xbryk (120 mg vial), ...
Posted by Michael Wonder on 02 Dec 2025
Australia’s PBS faces heat from Trump’s new drug pricing deal
2 December 2025 - Britain has agreed to pay 25% more for new medicines to escape Donald Trump’s pharmaceutical tariffs ...
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 ...
Posted by Michael Wonder on 02 Dec 2025
EMA validates type II variation application for Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) for certain patients with muscle-invasive bladder cancer
1 December 2025 - Astellas Pharma today announced that the EMA validated for review a type II variation application for ...