On Target Laboratories announces U.S. FDA acceptance and priority review of new drug application for pafolacianine sodium injection for identification of ovarian cancer during surgery

3 March 2021 - On Target Laboratories today announced that the U.S. FDA has accepted its new drug application for priority ...

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Medexus announces expanded availability of Gleolan in Canada

25 February 2021 - Medexus Pharmaceuticals announced today that it has initiated the commercial launch of Gleolan in Canada, which had ...

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TGA reviewing COVID-19 tests to rule out issues diagnosing variants

24 February 2021 - Adjunct Professor John Skerritt has tasked the nation’s medical regulator with ensuring COVID-19 tests are successfully ...

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Myriad Genetics receives first reimbursement decision for myChoice diagnostic system in Japan, enabling women with ovarian cancer to benefit from treatment with Zejula

8 January 2021 - Myriad Genetics announced today that it received its first reimbursement decision for the Myriad myChoice Diagnostic System, ...

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FDA acceptance for the filing of new drug application

23 December 2020 - The Directors are pleased to announce that Polarean has received notification of acceptance of the Company’s NDA ...

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FDA approves Bracco Diagnostics' ProHance (gadoteridol) Injection, 279.3 mg/mL, for paediatric patients younger than two years

23 December 2020 - Bracco Diagnostics today announced that the U.S. FDA has approved ProHance (gadoteridol 279.3 mg/mL injection) for ...

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US FDA approves world’s first rapid Covid test from Brisbane’s Ellume

16 March 2020 - The US FDA has approved the world’s first rapid at home COVID-19 test, developed by Brisbane-based ...

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Roche launches cobas PIK3CA mutation test for patients with advanced or metastatic breast cancer in countries accepting the CE mark

15 December 2020 - This genetic test identifies mutations in the PIK3CA gene that can cause cells to grow uncontrollably, which ...

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Avelas receives FDA breakthrough therapy designation for pegloprastide (AVB-620) for use during breast cancer surgery

14 December 2020 - Avelas Biosciences today announced that the company has received breakthrough therapy designation from the U.S. FDA ...

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Lantheus Holdings announces acceptance and priority review of new drug application for PyLTM (18F DCFPyL), a PSMA targeted prostate cancer PET imaging agent

9 December 2020 - PDUFA action date of 28 May 2021 assigned by U.S. FDA. ...

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Telix granted TGA priority review for prostate cancer imaging

7 December 2020 -  Telix announces today that the Company’s preliminary application to the TGA for TLX591-CDx was made at ...

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FDA approves first PSMA-targeted PET imaging drug for men with prostate cancer

1 December 2020 - Today, the U.S. FDA approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for ...

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Telix new drug application for prostate cancer imaging product accepted by US FDA

24 November 2020 - Telix Pharmaceuticals announces new drug application for TLX591-CDx. ...

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FDA authorises first COVID-19 test for self-testing at home

17 November 2020 - Today, the U.S. FDA issued an emergency use authorisation for the first COVID-19 diagnostic test for self-testing ...

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Health Canada approves Canada’s first HIV self test

3 November 2020 - For the first time, Canadians will have access to at-home HIV self test kits. bioLytical Laboratories ...

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