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 11 Apr 2023
RegenxBio receives FDA fast track designation for RGX-202, a novel gene therapy candidate for the treatment of Duchenne muscular dystrophy
11 April 2023 - RGX-202 is a potential one-time AAV therapeutic for the treatment of Duchenne and includes an optimised transgene ...
Posted by Michael Wonder on 11 Apr 2023
Health technology assessment policy and methods review consultation
11 April 2023 - The first round of public consultation for the HTA Review is open. Submissions will be accepted ...
Posted by Michael Wonder on 11 Apr 2023
New life saving medicines
11 April 2023 - The Australian Government has added the two medicines, Kanuma (sebelipase alfa) and Cerdelga (eliglustat) to the Life ...
Posted by Michael Wonder on 10 Apr 2023
Health care regulators’ outdated thinking will cost American ives
10 April 2023 - In a matter of months, ChatGPT has radically altered our nation’s views on artificial intelligence—uprooting old ...
Posted by Michael Wonder on 10 Apr 2023
COVID-19 vaccine safety report (6 April 2023)
6 April 2023 - To 2 April 2023, more than 44 million doses of Comirnaty (Pfizer) mRNA vaccines have been administered in ...
Posted by Michael Wonder on 10 Apr 2023
Cheaper medicines for graft versus host disease, chronic rhinosinusitis and oesophageal cancer
10 April 2023 - For the first time Jakavi (ruxolitinib) will be listed for the treatment of patients with either acute ...
Posted by Michael Wonder on 08 Apr 2023
Accord BioPharma announces US FDA acceptance of biologics license application for proposed biosimilar trastuzumab HLX02
5 April 2023 - The biosimilar for Herceptin seeks to treat several forms of HER2 cancer. ...
Posted by Michael Wonder on 08 Apr 2023
Federal judge stays FDA abortion pill approval, gives Biden administration time to appeal
7 April 2023 - A federal judge in Texas on Friday stayed the FDA’s approval of the abortion pill mifepristone, ...
Posted by Michael Wonder on 08 Apr 2023
NICE final draft guidance recommends olaparib for early breast cancer and metastatic prostate cancer following new commercial deals
6 April 2023 - Ground breaking commercial deals for the anti-cancer medicine olaparib have paved the way for hundreds to benefit ...
Posted by Michael Wonder on 07 Apr 2023
Update on Imbruvica (ibrutinib) US accelerated approvals for mantle cell lymphoma and marginal zone lymphoma indications
6 April 2023 - AbbVie announced today the intent to voluntarily withdraw, in the US, accelerated Imbruvica (ibrutinib) approvals for ...
Posted by Michael Wonder on 07 Apr 2023
FDA Commissioner and Chief Scientist announce decision to withdraw approval of Makena
6 April 2023 - Today, the US FDA announced the final decision to withdraw approval of Makena—a drug that had been ...
Posted by Michael Wonder on 06 Apr 2023
Enanta Pharmaceuticals receives FDA fast track designation for EDP-323, its oral, L-protein inhibitor in development for the treatment of respiratory syncytial virus
6 April 2023 - Enanta Pharmaceuticals today announced that the US FDA has granted fast track designation for EDP-323, Enanta’s ...
Posted by Michael Wonder on 06 Apr 2023
Trastuzumab deruxtecan for the treatment of patients with HER2 positive unresectable or metastatic gastric or gastro-oesophageal junction cancer after anti-HER2 treatment
6 April 2023 - NICE is unable to make a recommendation on the use of trastuzumab deruxtecan (Enhertu) for the treatment ...
Posted by Michael Wonder on 06 Apr 2023
AstraZeneca vaccine discontinued by Federal Government
5 April 2023 - One of the first COVID-19 jabs offered to Australians has been quietly discontinued, the Federal Government has ...
Posted by Michael Wonder on 06 Apr 2023
Public summary documents – December 2022 PBAC meeting
6 April 2023 - The public summary documents (positive recommendations and subsequent decisions not to recommend) from the December 2022 PBAC ...