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RSS FeedPosted by Michael Wonder on 15 Jun 2022
TGA approval of Kimmtrak
15 June 2022 - Tebentafusp is a bi-specific fusion protein. ...
Posted by Michael Wonder on 14 Jun 2022
Novavax COVID-19 vaccine Nuvaxovid provisionally registered in Australia as a booster in individuals aged 18 and over
13 June 2022 - In Australia, Nuvaxovid is the first protein-based COVID-19 vaccine registered for use as a booster regardless ...
Posted by Michael Wonder on 09 Jun 2022
COVID-19 vaccine weekly safety report (9 June 2022)
9 June 2022 - To 5 June 2022, the TGA has received 577 reports which have been assessed as likely to ...
Posted by Michael Wonder on 08 Jun 2022
The UK MHRA, Australian TGA and Health Canada approve Kimmtrak (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma
8 June 2022 - Kimmtrak demonstrated statistically and clinically meaningful overall survival benefit, hazard ratio of 0.51, with median overall survival ...
Posted by Michael Wonder on 06 Jun 2022
Medigen applies for Australian vaccine approval
7 June 2022 - Medigen Vaccine Biologics has applied to the Australian medicines regulator for provisional approval of its COVID-19 ...
Posted by Michael Wonder on 02 Jun 2022
COVID-19 vaccine weekly safety report (2 June 2022)
2 June 2022 - To 29 May 2022, the TGA has received 573 reports which have been assessed as likely to ...
Posted by Michael Wonder on 29 May 2022
ATAGI update following weekly COVID-19 meeting (25 May 2022)
27 May 2022 - An update from the Australian Technical Advisory Group on Immunisation (ATAGI) following their weekly meeting on 25 ...
Posted by Michael Wonder on 26 May 2022
COVID-19 vaccine weekly safety report (26 May 2022)
26 May 2022 - To 22 May 2022, the TGA has received 555 reports which have been assessed as likely to ...
Posted by Michael Wonder on 26 May 2022
Prescription medicines: applications under evaluation (May 2022)
26 May 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...
Posted by Michael Wonder on 26 May 2022
TGA approves new medicine for patients with Cushing's syndrome
26 May 2022 - Osilodrostat phosphate is a cortisol synthesis inhibitor. ...
Posted by Michael Wonder on 25 May 2022
Expanded ATAGI recommendations on winter COVID-19 booster doses for people at increased risk of severe COVID-19
25 May 2022 - The Australian Technical Advisory Group on Immunisation (ATAGI) have expanded their recommendations on the use of additional ...
Posted by Michael Wonder on 23 May 2022
ATAGI update following weekly COVID-19 meeting (18 May 2022)
23 May 2022 - An update from the Australian Technical Advisory Group on Immunisation (ATAGI) following their weekly meeting on 18 ...
Posted by Michael Wonder on 19 May 2022
COVID-19 vaccine weekly safety report (19 May 2022)
19 May 2022 - To 15 May 2022, the TGA has received 555 reports which have been assessed as likely to ...
Posted by Michael Wonder on 16 May 2022
Pfizer settles two lawsuits, starts another over etanercept biosimilar in Australia
17 May 2022 - After agreeing to settle with Amgen over its oncology biosimilars, Pfizer issued a new patent lawsuit ...
Posted by Michael Wonder on 13 May 2022
TGA commences evaluation of Moderna COVID-19 vaccine (Spikevax) for children aged 6 months to 5 years old
13 May 2022 - The TGA has received, and immediately commenced evaluation of, an application from Moderna to extend the ...