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 25 Jan 2021
TGA provisionally approves Pfizer/BioNTech COVID-19 vaccine for use in Australia
25 January 2021 - The Therapeutic Goods Administration has provisionally approved the Pfizer/BioNTech COVID-19 vaccine for use in Australia. ...
Posted by Michael Wonder on 25 Jan 2021
European Commission approves Bavencio (avelumab) for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma
25 January 2021 - BAVENCIO maintenance treatment significantly extended median overall survival versus standard of care in the Phase 3 JAVELIN ...
Posted by Michael Wonder on 25 Jan 2021
FDA grants toripalimab fast track designation for mucosal melanoma
25 January 2021 - Junshi Biosciences announced today that U.S. FDA has granted toripalimab fast track designation for the first-line treatment ...
Posted by Michael Wonder on 24 Jan 2021
TGA provisionally approves Pfizer COVID-19 vaccine
25 January 2021 - The Therapeutic Goods Administration has granted provisional approval to Pfizer Australia for its COVID-19 vaccine, Comirnaty, ...
Posted by Michael Wonder on 24 Jan 2021
Creating a patient and community advisory committee at the Canadian Agency for Drugs and Technologies in Health
22 January 2021 - In recognition of patients’ roles using, and contributing to, a publicly funded health system, the Canadian Agency ...
Posted by Michael Wonder on 24 Jan 2021
TGA to give Australians confidence to get the COVID-19 jab
22 January 2021 - COVID-19 vaccines will play a major role in fighting the coronavirus pandemic. ...
Posted by Michael Wonder on 24 Jan 2021
The stakes for choosing the right FDA commissioner couldn’t be higher
24 January 2021 - An independent, credible, science led Food and Drug Administration has long been vital to America’s public, ...
Posted by Michael Wonder on 24 Jan 2021
Canada’s drug makers rattle their sabers over a government plan to control medicine spending
21 January 2021 - A majority of pharmaceutical executives in Canada say new regulations designed to cut prescription drug spending ...
Posted by Michael Wonder on 24 Jan 2021
Australia ‘on track’ for coronavirus vaccines despite global shortages
24 January 2021 - Josh Frydenberg has insisted that Australia’s vaccine rollout is still on track, despite tensions heating up over ...
Posted by Michael Wonder on 24 Jan 2021
Calls to expand vaccine portfolio after Government fails to secure Moderna vaccine
25 January 2021 - Health experts are calling for Australia to expand its suite of COVID-19 vaccines amid concern the ...
Posted by Michael Wonder on 24 Jan 2021
BioCryst announces approval of Orladeyo (berotralstat) in Japan for the prophylactic treatment of hereditary angioedema
22 January 2021 - BioCryst Pharmaceuticals today announced that the Ministry of Health, Labor and Welfare in Japan has granted ...
Posted by Michael Wonder on 23 Jan 2021
FDA approves Aurinia Pharmaceuticals’ Lupkynis (voclosporin) for adult patients with active lupus nephritis
22 January 2021 - Lupkynis is the first FDA approved oral therapy for lupus nephritis, a condition that causes irreversible kidney ...
Posted by Michael Wonder on 22 Jan 2021
ICER publishes evidence report on therapies for high cholesterol
22 January 2021 - The evidence suggests that inclisiran can substantially lower LDL-C with limited safety concerns, and with a ...
Posted by Michael Wonder on 22 Jan 2021
FDA approves nivolumab plus cabozantinib for advanced renal cell carcinoma
22 January 2021 - Today the FDA approved the combination of nivolumab (Opdivo, Bristol-Myers) and cabozantinib (Cabometyx, Exelixis) as ...
Posted by Michael Wonder on 22 Jan 2021
ICER releases draft evidence report on therapies for lupus nephritis
22 January 2021 - Public comment period now open until 18 February 2021; requests to make oral comment during public meeting ...