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RSS FeedPosted by Michael Wonder on 23 May 2023
Lumicell announces FDA acceptance and priority review of new drug application for Lumisight optical imaging agent for breast cancer
22 May 2023 - The system visually highlights cancer that may have otherwise been left behind and is designed to be ...
Posted by Michael Wonder on 16 Mar 2023
FDA approves expanded indication for Telix's Illuccix to include patient selection for PSMA directed radioligand therapy
16 March 2023 - Telix Pharmaceuticals today announces that the US FDA has approved a supplementary new drug application for ...
Posted by Michael Wonder on 06 Mar 2023
Roche receives FDA approval of label expansion for Ventana PD-L1 (SP263) assay to identify patients with locally advanced and metastatic non-small cell lung cancer eligible for Libtayo
6 March 2023 - The Ventana PD-L1 (SP263) assay helps determine which patients with non-small cell lung cancer may be eligible ...
Posted by Michael Wonder on 05 Jan 2023
FoundationOne Liquid CDx receives FDA approval as a companion diagnostic for Rozlytrek (entrectinib)
4 January 2023 - Foundation Medicine’s liquid biopsy test can now be used by oncologists to identify more patients with rare ...
Posted by Michael Wonder on 05 Jan 2023
OncoNano Medicine’s pegsitacianine granted breakthrough therapy designation for real-time surgical imaging by the FDA
4 January 2023 - OncoNano Medicine today announced that its lead clinical development candidate, pegsitacianine, a pH sensitive fluorescent nanoprobe ...
Posted by Michael Wonder on 29 Dec 2022
FDA approves Polarean’s Xenoview (Xenon Xe 129 hyperpolarised) for use with MRI for the evaluation of lung ventilation
28 December 2022 - FDA approved indication includes both adolescents and adults representing a significant market opportunity ...
Posted by Michael Wonder on 18 Dec 2022
On Target Laboratories announces expanded indication of Cytalux (pafolacianine) injection for detection of lung cancer during surgery
16 December 2022 - Cyralux is also the first and only targeted molecular imaging agent that illuminates ovarian cancer in ...
Posted 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 ...