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 20 Aug 2022
Axsome Therapeutics announces FDA approval of Auvelity, the first and only oral NMDA receptor antagonist for the treatment of major depressive disorder in adults
19 August 2022 - Auvelity is the first and only rapid-acting oral treatment approved with labelling of statistically significant improvement in ...
Posted by Michael Wonder on 20 Aug 2022
Health Canada approves COVID-19 booster dose for kids 5 to 11
19 August 2022 - The 10 mcg dose can be given at least 6 months after primary series is completed. ...
Posted by Michael Wonder on 20 Aug 2022
European Commission approves Celltrion Healthcare’s Vegzelma (CT-P16, biosimilar bevacizumab) for the treatment of multiple types of cancer
18 August 2022 - Vegzelma offers European patients living with certain types of breast, lung, renal, colon, rectum, ovarian and cervical ...
Posted by Michael Wonder on 20 Aug 2022
Kapruvia approved in Switzerland with additional regulatory decisions expected in H2, 2022
19 August 2022 - Regulatory decisions in Australia and Singapore expected by the end of 2022. ...
Posted by Michael Wonder on 20 Aug 2022
Fresenius Kabi announces acceptance of its marketing authorisation application by the European Medicines Agency for MSB11456, a tocilizumab biosimilar candidate
18 August 2022 - Fresenius Kabi announced today that its marketing authorisation application for MSB11456, the company’s tocilizumab biosimilar candidate, ...
Posted by Michael Wonder on 19 Aug 2022
European Commission approves Oncopeptides' Pepaxti for the treatment of patients with relapsed refractory multiple myeloma
18 August 2022 - Oncopeptides today announces that the European Commission has granted Pepaxti (melphalan flufenamide) marketing authorisation in combination ...
Posted by Michael Wonder on 19 Aug 2022
Recommendations made by the PBAC - July 2022
19 August 2022 - The recommendations from the July 2022 PBAC meeting are now available. ...
Posted by Michael Wonder on 19 Aug 2022
FDA accepts Krystal Biotech’s biologics license application for dystrophic epidermolysis bullosa
18 August 2022 - FDA granted priority review designation. ...
Posted by Michael Wonder on 19 Aug 2022
1 September 2022 updates as part of the digital transformation of authority required (written) PBS listings
19 August 2022 - From 1 September 2022, the PBS listings for certain cancer medicines will be updated as part of ...
Posted by Michael Wonder on 19 Aug 2022
Aeglea BioTherapeutics announces European Medicines Agency validation of marketing authorisation application for pegzilarginase for the treatment of arginase 1 deficiency
18 August 2022 - Aeglea BioTherapeutics today announced that a marketing authorisation application for pegzilarginase for the treatment of arginase 1 ...
Posted by Michael Wonder on 18 Aug 2022
Stability of changes in health status: next step in comprehensively assessing patient reported outcomes
18 August 2022 - Chronic diseases can impair patients’ health status due to symptoms, functional limitations, and impaired quality of life. ...
Posted by Michael Wonder on 18 Aug 2022
Canadians seek diabetes medication as replacement for weight loss drug during arrival delays
18 August 2022 - High demand in the United States for a new weight-loss medication has indefinitely delayed its arrival ...
Posted by Michael Wonder on 18 Aug 2022
AARP Pennsylvania convenes discussion on lower prescription drug costs after Inflation Reduction Act signed into law
18 August 2022 - Senator Bob Casey joins AARP Discussion. ...
Posted by Michael Wonder on 18 Aug 2022
Caps on prescription drug price hikes most popular aspect of Inflation Reduction Act: poll
18 August 2022 - A cap on prescription drug price increases is the most popular part of the Inflation Reduction ...
Posted by Michael Wonder on 18 Aug 2022
CSL Vifor plans UK launch after NICE backs rare disease drug Tavneos
18 August 2022 - UK cost-effectiveness organisation NICE has recommended routine NHS use of a recently approved therapy for two ...