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RSS FeedPosted by Michael Wonder on 28 Nov 2022
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. ...
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 24 Oct 2022
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 ...
Posted by Michael Wonder on 14 Oct 2022
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) ...
Posted by Michael Wonder on 28 Sep 2022
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 ...
Posted by Michael Wonder on 27 Sep 2022
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 ...
Posted by Michael Wonder on 26 Sep 2022
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 ...
Posted by Michael Wonder on 23 Sep 2022
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 ...
Posted by Michael Wonder on 21 Sep 2022
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 ...
Posted by Michael Wonder on 13 Sep 2022
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. ...
Posted by Michael Wonder on 07 Sep 2022
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 ...
Posted by Michael Wonder on 25 Aug 2022
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 ...
Posted by Michael Wonder on 23 Aug 2022
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 ...
Posted by Michael Wonder on 13 Aug 2022
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 ...
Posted by Michael Wonder on 11 Aug 2022
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 ...