Pharmacists struggle to meet demand for free COVID test kits amid stock shortage

23 January 2022 - Chemists across the country say they do not have enough rapid antigen tests to start handing ...

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TGA ‘knowingly putting pharmacists in serious danger’

18 January 2022 - The pharmacists’ union has accused the medical regulator of putting workers and customers at risk of ...

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Biden-Harris Administration requires insurance companies and group health plans to cover the cost of at home COVID-19 tests, increasing access to free tests

10 January 2022 - As part of its on-going efforts across many channels to expand Americans’ access to free testing, the ...

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FDA approves Telix’s prostate cancer imaging product, Illuccix

19 December 2021 - Telix Pharmaceuticals today announces that the United States FDA has approved Telix’s lead prostate cancer imaging product, ...

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FDA approves NGS based companion diagnostic for EGFR exon20 insertion mutant non-small-cell lung cancer tumour tissue

9 December 2021 - Oncomine Dx Target Test now approved for 12 NSCLC targeted therapies globally. ...

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FoundationOne CDx receives FDA approval as a companion diagnostic for BRAF inhibitor therapeutics in melanoma

8 December 2021 - Foundation Medicine’s tissue-based test is the first and only comprehensive genomic profiling test to be approved as ...

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FDA approves new imaging drug to help identify ovarian cancer lesions

29 November 2021 - The U.S. Food and Drug Administration today approved Cytalux (pafolacianine), an imaging drug intended to assist ...

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MSAC publishes agenda for upcoming meeting

24 November 2021 - 10 agenda items for consideration at the 31 March - 1 April 2022 meeting. ...

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TGA approves Illuccix for prostate cancer imaging

2 November 2021 - Telix is delighted to announce that the TGA has approved Illuccix (kit for the preparation of ...

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Roche’s Ventana PD-L1 (SP263) assay receives FDA approval as a companion diagnostic to identify certain non-small-cell lung cancer patients eligible for Tecentriq (atezolizumab)

22 October 2021 - The Ventana PD-L1 (SP263) assay helps determine which non-small-cell lung cancer patients may benefit from treatment with ...

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FDA grants breakthrough device designation for Biological Dynamics’ early stage pancreatic cancer detection test

20 October 2021 - Designation provides expedited regulatory review of Exo-PDAC, a liquid biopsy assay, built on the company’s Verita ...

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COVID-19 rapid antigen self-tests approved in Australia

13 October 2021 - The TGA has approved COVID-19 self-tests (home use tests) for supply in Australia from 1 November ...

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Agilent receives FDA companion diagnostic approval for Ki-67 IHC MIB-1 pharmDx in high risk early breast cancer

13 October 2021 - Agilent Technologies today announced its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is now FDA approved as ...

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Complete response letter received from FDA

6 October 2021 - Requirement to address approvability issues identified by FDA ahead of NDA resubmission ...

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Jubilant Radiopharma announces Eckert & Ziegler's GalliaPharm approved for use with NETSpot in Canada

22 September 2021 - Jubilant Radiopharma is the exclusive distributor of GalliaPharm in Canada. ...

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