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 09 Feb 2021
U.S. FDA grants breakthrough device designation to Vascular Perfusion Solutions for its visionary VP.S Encore cardiac transport device
8 February 2021 - The U.S. Food and Drug Administration (FDA) has granted Vascular Perfusion Solutions, Inc. (VPS) a Breakthrough Device ...
Posted by Michael Wonder on 09 Feb 2021
ViiV Healthcare receives marketing authorisation for Rukobia (fostemsavir), a first-in-class attachment inhibitor in combination with other antiretrovirals for the treatment of adults with multidrug-resistant HIV
8 February 2021 - Fostemsavir addresses a critical need in HIV care for those with little to no treatment options left ...
Posted by Michael Wonder on 09 Feb 2021
Pfizer vaccine bound for Australia won’t be blocked
9 February 2021 - Europe will not delay the first doses of Pfizer vaccine bound for Australia despite moves to block ...
Posted by Michael Wonder on 09 Feb 2021
Teen thriving on PHARMAC funded medicine
9 February 2021 - 14 year old Bruno Cettina is living his best life thanks to a medicine funded by PHARMAC. ...
Posted by Michael Wonder on 09 Feb 2021
Novartis receives FDA breakthrough therapy designations for investigational STAMP inhibitor asciminib (ABL001) in chronic myeloid leukaemia
8 February 2021 - Designation in patients with chronic myeloid leukaemia (CML) resistant or intolerant to prior treatments based on positive ...
Posted by Michael Wonder on 09 Feb 2021
ShiraTronics receives FDA breakthrough device designation for chronic migraine neurostimulation
8 February 2021 - ShiraTronics announced today that it has been granted a breakthrough device designation by the Center of Devices ...
Posted by Michael Wonder on 08 Feb 2021
S Africa suspends COVID-19 vaccination over AstraZeneca study as WHO deliberates on usage
9 February 2021 - The World Health Organisation will decide on recommended usage of the AstraZeneca-Oxford vaccine after a study showed ...
Posted by Michael Wonder on 08 Feb 2021
COVID-19 vaccine certificates to be available online within days of immunisation
8 February 2021 - Australians will have access to their COVID-19 immunisation certificates within days of receiving the vaccine, with ...
Posted by Michael Wonder on 08 Feb 2021
SMC - February 2021 decisions
8 February 2021 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 08 Feb 2021
Ellodi Pharmaceuticals announces fast track designation granted by the FDA to APT-1011 for the treatment of eosinophilic osophagitis
8 February 2021 - Ellodi Pharmaceuticals today announced that APT-1011 (fluticasone propionate oral disintegrating tablet) has been granted fast track designation ...
Posted by Michael Wonder on 08 Feb 2021
International regulators working together to enhance collaboration on COVID-19 observational research
8 February 2021 - In a dedicated COVID-19 workshop, convened under the umbrella of the International Coalition of Medicines Regulatory Authorities, ...
Posted by Michael Wonder on 08 Feb 2021
FDA grants breakthrough device designation for Roche's Elecsys growth differentiation factor-15 assay to help identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients
8 February 2021 - FDA BDD acknowledges the importance of GDF-15 testing in identifying eligible cachexic patients with solid tumours to ...
Posted by Michael Wonder on 08 Feb 2021
Puzzle Medical Devices receives U.S. FDA breakthrough device designation for its revolutionary minimally invasive transcatheter heart pump
8 February 2021 - Puzzle Medical Devices announced today that the U.S. FDA has granted the company a breakthrough revice designation ...
Posted by Michael Wonder on 08 Feb 2021
TGA one of only five non-European regulators invited to participate on European committees on COVID-19 vaccines and therapeutics
8 February 2021 - Australia, through the TGA, is one of only five non-European Union regulators formally invited to participate ...
Posted by Michael Wonder on 07 Feb 2021
Australians to have proof of their coronavirus vaccination on their smartphone
7 February 2021 - The Federal Government has revealed further details of its COVID-19 vaccination plan, confirming Australians will be ...