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 22 Aug 2022
Monkeypox vaccines not expected until December
20 August 2022 - Monkeypox vaccines aren't expected to arrive in New Zealand until December, according to PHARMAC. ...
Posted by Michael Wonder on 22 Aug 2022
EMA’s Emergency Task Force advises on intradermal use of Imvanex/Jynneos against monkeypox
19 August 2022 - EMA’s Emergency Task Force (ETF) has reviewed data on the monkeypox vaccine Imvanex used as an ...
Posted by Michael Wonder on 22 Aug 2022
Kyowa Kirin receives European Commission approval for use of Crysvita (burosumab) for the treatment of tumour-induced osteomalacia
19 August 2022 - Crysvita is the first approved biologic treatment in the EU for patients with tumour-induced osteomalacia who cannot ...
Posted by Michael Wonder on 22 Aug 2022
National Medicines Policy review – registrations for targeted stakeholder consultation sessions and open public forum
22 August 2022 - The Department of Health and Aged Care is inviting stakeholders to provide feedback on the revised ...
Posted by Michael Wonder on 22 Aug 2022
TGA grants provisional determination for sabizabulin for the treatment of COVID-19
22 August 2022 - On 19 August 2022, the TGA granted a provisional determination to Adjutor Healthcare for a new ...
Posted by Michael Wonder on 21 Aug 2022
Ozempic restrictions for weight loss ‘unfair’, obesity expert says
21 August 2022 - A diabetes drug proven to help with weight loss has been limited for use in diabetics only— ...
Posted by Michael Wonder on 20 Aug 2022
Pharma’s likely to sue over Medicare negotiation. Here are the arguments they might use.
18 August 2022 - Democrats finally achieved a win over the pharmaceutical industry this month when they passed the most ...
Posted by Michael Wonder on 20 Aug 2022
Father invents balance treatment device for daughter; makes history with FDA clearance AND breakthrough device designation
18 August 2022 - GyroStim, a multi-axis rotational chair, was invented by a Colorado father in his garage to aid ...
Posted by Michael Wonder on 20 Aug 2022
Improving the use of FDA Advisory Committees
20 August 2022 - Advisory committees cannot support public trust in FDA decisions if the agency uses them inconsistently. ...
Posted by Michael Wonder on 20 Aug 2022
New reforms to prescription drug pricing in the US: opportunities and challenges
19 August 2022 - After several failed legislative efforts over the past decade, in August 2022, Congress enacted prescription drug pricing ...
Posted by Michael Wonder on 20 Aug 2022
Regulatory considerations to keep pace with innovation in digital health products
19 August 2022 - Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital ...
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. ...