Blog
RSS FeedPosted by Michael Wonder on 04 Jul 2023
Biomarker tests for targeted oncology therapies pose tricky regulatory challenges
29 June 2023 - The US FDA recently announced the launch of a year-long pilot programme regarding diagnostic methods within oncology ...
Posted by Michael Wonder on 03 Jul 2023
Roche receives FDA clearance for additional Alzheimer's disease cerebrospinal fluid assays, supporting timely diagnosis and treatment decision-making
27 June 2023 - The Elecsys tTau/Abeta42 ratio helps clinicians define Alzheimer's disease biologically and expands Roche's Alzheimer's CSF portfolio to ...
Posted by Michael Wonder on 28 Jun 2023
FDA approves Bayer’s Ultravist (iopromide) injection for contrast-enhanced mammography
23 June 2023 - Ultravist-300, -370 is now the only contrast agent in the US indicated to visualise known or suspected ...
Posted by Michael Wonder on 30 May 2023
US FDA approves Blue Earth Diagnostics’ Posluma (flotufolastat F 18) injection, first radiohybrid PSMA targeted PET imaging agent for prostate cancer
30 May 2023 - Posluma will be commercially available in the United States in early June 2023. ...
Posted 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) ...