Lantheus announces the approval of Definity (perflutren lipid microsphere) by China’s NMPA

28 November 2022 - Definity is the leading diagnostic ultrasound enhancing agent for patients with suboptimal echocardiograms. ...

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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 ...

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Invivoscribe files sPMA with the FDA for use of the LeukoStrat CDx FLT3 mutation assay to select patients with newly diagnosed FLT3-ITD positive AML

24 October 2022 -  Invivoscribe is pleased to announce that they have filed a supplemental pre-market approval submission with the ...

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Health Canada approves Illuccix for prostate cancer imaging

13 October 2022 - Telix Pharmaceuticals announces that Health Canada has approved Illuccix [kit for the preparation of gallium (Ga 68) ...

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Thermo Fisher Scientific announces FDA approval of Oncomine Dx Target Test as the first NGS based companion diagnostic to aid in therapy selection for patients with RET mutations/fusions in thyroid cancers

27 September 2022 - Approval also marks the second NGS based companion diagnostic to identify RET fusion positive locally advanced or ...

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Blue Earth Diagnostics announces FDA acceptance of new drug application for 18F-rhPSMA-7.3, a radiohybrid prostate specific membrane antigen targeted PET imaging agent for prostate cancer

27 September 2022 - Blue Earth Diagnostics today announced that the US FDA has accepted its filing for a new ...

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Better Therapeutics submits de novo request to US FDA for BT-001 investigational prescription digital therapy for type 2 diabetes

22 September 2022 - Submission follows completion of first in class trial demonstrating significant improvements in A1c reduction with investigational therapy ...

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Bracco announces FDA approval of gadopiclenol injection, a new macrocyclic high-relaxivity gadolinium-based contrast agent which will be commercialised as Vueway

21 September 2022 - Vueway injection is highly stable and shows the highest relaxivity among gadolinium-based contrast agents available for ...

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Guerbet announces US FDA approval of Elucirem (gadopiclenol)

21 September 2022 - FDA approval of Elucirem was granted after priority review, a designation assigned to applications for drugs ...

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BWXT Medical submits Tc 99m generator new drug application to FDA

13 September 2022 - Company highlights growing nuclear medicine product portfolio and future opportunities in therapeutic radioisotopes. ...

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First combination COVID-19 and influenza self-tests approved for Australia

7 September 2022 - The TGA has approved the first two nasal combination self-tests (for use at home) that detect ...

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Myriad Genetics receives expanded coverage in Japan for use of BRACAnalysis Diagnostic System as a companion diagnostic for Lynparza in early-stage breast cancer

25 August 2022 - Myriad Genetics today announced Japan’s MHLW has granted expanded coverage for the use of Myriad’s BRACAnalysis ...

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Pillar Biosciences receives China National Medical Products Administration approval for oncoReveal Dx colon cancer assay

22 August 2022 - Highly accurate, tissue based, next generation sequencing test approved in China as a companion diagnostic for ...

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FDA approves first NGS based companion diagnostic to aid in selecting non-small-cell lung cancer patients with HER2 (ERBB2) activating mutations (SNVs & exon 20 insertions) for treatment with Enhertu

12 August 2022 - This approval marks the Oncomine Dx Target Test’s eighth companion diagnostic therapy selection indication ...

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Roche receives FDA approval for VENTANA MMR RxDx panel to identify dMMR solid tumour patients and pMMR endometrial cancer patients eligible for Keytruda

11 August 2022 - Based on cancer biomarkers, the first-of-its-kind VENTANA MMR RxDx Panel helps identify solid tumour patients, including endometrial ...

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