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 17 Nov 2022
New COVID-19 vaccines for eligible Australians
15 November 2022 - The Australian Government has accepted a recommendation from the Australian Technical Advisory Group on Immunisation (ATAGI) on ...
Posted by Michael Wonder on 16 Nov 2022
TGA grants provisional determination to Pfizer’s COVID-19 bivalent (Comirnaty Bivalent Omicron BA.4/BA.5) booster dose vaccine
16 November 2022 - On 15 November 2022, the TGA granted a provisional determination to Pfizer’s bivalent COVID-19 vaccine candidate: tozinameran ...
Posted by Michael Wonder on 16 Nov 2022
Ruxolitinib phosphate for the treatment of patients with acute graft versus host disease that is refractory to the use of corticosteroids
16 November 2022 - NICE is unable to make a recommendation about the use in the NHS of ruxolitinib phosphate for ...
Posted by Michael Wonder on 15 Nov 2022
Expansion of access to MenB vaccine urgently needed
15 November 2022 - Meningococcal B is a rare but very serious disease, causing death and serious long-term disabilities. Even when ...
Posted by Michael Wonder on 15 Nov 2022
This is how access to older antibiotics can be strengthened
14 November 2022 - Shortages in access to antibiotics can pose serious obstacles to responsible antibiotic treatment - and a survey ...
Posted by Michael Wonder on 15 Nov 2022
ATAGI recommendations on use of the Pfizer COVID-19 vaccine for children aged 6 months to 4 years
15 November 2022 - On 29 September 2022, the TGA provisionally approved Comirnaty (Pfizer) COVID-19 vaccine for use in children ...
Posted by Michael Wonder on 15 Nov 2022
PerkinElmer announces its EONIS SCID-SMA kit is first to receive marketing authorisation by US FDA for SMA screening in newborns
14 November 2022 - Building on its contributions to newborn screening globally, PerkinElmer’s latest FDA authorised assay enables the simultaneous ...
Posted by Michael Wonder on 15 Nov 2022
ATAGI recommendations on use of the Pfizer bivalent (Original/Omicron BA.1) COVID-19 vaccine
15 November 2022 - On 27 October 2022, the TGA provisionally approved the Pfizer (Comirnaty) Bivalent Original/Omicron BA.1 vaccine (subsequently referred ...
Posted by Michael Wonder on 15 Nov 2022
FDA approves Medicines360's Liletta (levonorgestrel releasing intrauterine system) 52 mg to prevent pregnancy for up to eight years
14 November 2022 - FDA approval of extended duration of use supports Medicines360's mission to expand women's access. ...
Posted by Michael Wonder on 15 Nov 2022
ATAGI update on boosters following COVID-19 meeting on 11 November 2022
15 November 2022 - An update from the Australian Technical Advisory Group on Immunisation (ATAGI) following their meeting on 11 November ...
Posted by Michael Wonder on 15 Nov 2022
Lynparza in combination with abiraterone recommended for approval in the EU by CHMP as first-line treatment for patients with metastatic castration-resistant prostate cancer
14 November 2022 - First PARP inhibitor to demonstrate clinical benefit in combination with a new hormonal agent in this ...
Posted by Michael Wonder on 15 Nov 2022
Junshi Biosciences announces submission of a marketing authorisation application to the European Medicines Agency for toripalimab
14 November 2022 - The MAA was submitted in the EU for toripalimab seeking indications for the first-line treatment of NPC ...
Posted by Michael Wonder on 15 Nov 2022
Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2 positive advanced gastric cancer
14 November 2022 - Based on DESTINY-Gastric02, which showed Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated clinically meaningful efficacy and DESTINY-Gastric01, which ...
Posted by Michael Wonder on 15 Nov 2022
COVID-19 vaccine safety report (3 November 2022)
3 November 2022 - To 30 October 2022, the TGA has received 704 reports which have been assessed as likely to ...
Posted by Michael Wonder on 15 Nov 2022
FDA grants accelerated approval to mirvetuximab soravtansine-gynx for folate receptor alfa positive, platinum resistant epithelial ovarian, fallopian tube, or peritoneal cancer
14 November 2022 - Today the FDA granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere, ImmunoGen) for adult patients with folate ...