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 24 Oct 2021
Small Pharma granted fast track designation from UK regulator for DMT assisted therapy for major depressive disorder
21 October 2021 - Small Pharma is pleased to announce that following discussions with the U.K. MHRA, Small Pharma has been ...
Posted by Michael Wonder on 24 Oct 2021
Taking the pressure off high blood pressure
23 October 2021 - The Australian Government is investing $40.5 million for a new Medicare Benefits Schedule item to improve the ...
Posted by Michael Wonder on 24 Oct 2021
Medicare rebates for bowel inflammation testing
24 October 2021 - From 1 November 2021, patients with chronic bowel inflammation will be able to claim a Medicare rebate ...
Posted by Michael Wonder on 24 Oct 2021
Breast cancer treatment expanded on the Pharmaceutical Benefits Scheme
24 October 2021 - The Morrison Government is helping improve access to an important treatment for Australians battling a form of ...
Posted by Michael Wonder on 24 Oct 2021
EU decision on Russia's Sputnik V shot 'impossible' this year
21 October 2021 - The EU drug regulator is unlikely to decide whether to approve Russia's Sputnik V coronavirus vaccine until ...
Posted by Michael Wonder on 23 Oct 2021
Sio Gene Therapies announces granting of FDA fast track designation for investigational AXO-AAV-GM1 (AAV9-GLB1) gene therapy in patients with GM1 gangliosidosis
21 October 2021 - Sio Gene Therapies today announced that the U.S. FDA has granted fast track designation to AXO-AAV-GM1, its ...
Posted by Michael Wonder on 23 Oct 2021
Drug pricing talks heat up as Democrats work to win over skeptics
22 October 2021 - As drug pricing talks in Congress heated up this week, Democrats negotiated in earnest to get ...
Posted by Michael Wonder on 23 Oct 2021
Pre-implantation genetic testing for IVF to be covered by Medicare
24 October 2021 - Parents who fear passing on their hereditary diseases to children will now get genetic tests covered by ...
Posted by Michael Wonder on 23 Oct 2021
TGA to consider booster doses as health authorities assure the fully vaccinated that they are protected
23 October 2021 - Australia's medical regulator will look at new data from Pfizer on COVID-19 booster doses on Monday, with ...
Posted by Michael Wonder on 22 Oct 2021
Oncopeptides withdraws Pepaxto in US, scale down organisation and focus on R&D
22 October 2021 - Oncopeptides today announces that the company has decided to withdraw Pepaxto (melphalan flufenamide) from the market ...
Posted by Michael Wonder on 22 Oct 2021
Agenus provides update on balstilimab development
22 October 2021 - Company voluntarily withdraws biologics license application at FDA’s recommendation following full approval of pembrolizumab, which came four months ...
Posted by Michael Wonder on 22 Oct 2021
FDA approves Roche’s Susvimo, a first of its kind therapeutic approach for neovascular or “wet” age-related macular degeneration
22 October 2021 - Susvimo, previously called Port Delivery System with ranibizumab, is the first neovascular age-related macular degeneration treatment in ...
Posted by Michael Wonder on 21 Oct 2021
Ultimovacs receives dual FDA fast track designation for UV1 in advanced malignant melanoma
21 October 2021 - UV1 as add-on therapy to checkpoint inhibitors awarded fast track designation. ...
Posted by Michael Wonder on 21 Oct 2021
FDA issues draft guidance for industry on data standards for drug and biological product submissions containing real world data
21 October 2021 - Today, the U.S. FDA issued a draft guidance for industry titled Data Standards for Drug and Biological ...
Posted by Michael Wonder on 21 Oct 2021
FDA takes additional actions on the use of a booster dose for COVID-19 vaccines
20 October 2021 - Today, the U.S. FDA took action to expand the use of a booster dose for COVID-19 vaccines ...