Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 08 Aug 2022
Bot Image receives FDA clearance for artificial intelligence software used in detection and diagnosis of prostate cancer
8 August 2022 - Bot Image has developed an AI driven medical device CAD software to significantly improve the accuracy and ...
Posted by Michael Wonder on 31 Jul 2022
FDA provides update on agency response to monkeypox outbreak
29 July 2022 - Today, the U.S. FDA is providing an update on its multi-pronged response to monkeypox in the United ...
Posted by Michael Wonder on 27 Jul 2022
FDA grants import discretion of Bracco's iodinated contrast medium Iomeron (iomeprol) to address supply shortages
27 July 2022 - Bracco Diagnostics today announced that the U.S. FDA granted import discretion of Iomeron (iomeprol) into the ...
Posted by Michael Wonder on 12 Jul 2022
Provepharm announces that it has received FDA approval for Bludigo (indigotindisulfonate sodium, USP) injection
12 July 2022 - Bludigo is the first and only indigotindisulfonate sodium injection, USP, drug product approved by the FDA. ...
Posted by Michael Wonder on 28 Jun 2022
Curium announces the submission of its marketing authorisation application for [18F]-DCFPyL to the EMA
27 June 2022 - Submission follows the completion of Phase III PYTHON clinical trial of [18F]-DCFPyL for recurrent prostate cancer in ...
Posted by Michael Wonder on 09 Jun 2022
U.S. FDA approves Foundation Medicine’s FoundationOne CDx as a companion diagnostic for Roche’s Rozlytrek (entrectinib)
9 June 2022 - This approval marks the first and only companion diagnostic indication for Rozlytrek, and another important milestone in ...
Posted by Michael Wonder on 17 May 2022
FDA authorises first COVID-19 test available without a prescription that also detects influenza and RSV
16 May 2022 - The EUA authorises at home sample collection with testing performed in a laboratory. ...
Posted by Michael Wonder on 19 Apr 2022
iHealthScreen announces TGA approval for iPredict automated AI system for early diagnosis of diabetic retinopathy, age-related macular degeneration and glaucoma suspect
19 April 2022 - iHealthScreen is the first company in the USA to receive a CE certification, Australian Health approval, and ...
Posted by Michael Wonder on 05 Apr 2022
Curium announces FDA approval of a generic version of DaTscan (Ioflupane I 123 injection) in the U.S.
5 April 2022 - Curium announced today that its generic version of DaTscan (Ioflupane I 123 injection) was approved on 30 ...
Posted by Michael Wonder on 31 Mar 2022
New drug application resubmission
31 March 2022 - NDA submission for Polarean’s hyperpolarised 129Xenon gas drug device combination product ...
Posted by Michael Wonder on 29 Mar 2022
Gadopiclenol marketing authorisation dossier submissions accepted for review by EMA and FDA
29 March 2022 - Priority review granted by U.S. FDA. ...
Posted by Michael Wonder on 23 Feb 2022
Theragnostics announces US FDA approval for its radiodiagnostic imaging drug NephroScan (kit for the preparation of Technetium Tc 99m succimer injection)
23 February 2022 - NephroScan is now U.S. FDA approved for the preparation of Tc-99m DMSA. ...
Posted by Michael Wonder on 21 Feb 2022
U.S. FDA approves FoundationOne CDx as a companion diagnostic for Keytruda (pembrolizumab) to identify patients with microsatellite instability-high solid tumours
21 February 2022 - Foundation Medicine’s tissue-based comprehensive genomic profiling test is now the first and only FDA approved companion diagnostic ...
Posted by Michael Wonder on 16 Feb 2022
GE Healthcare's stress agent Rapiscan approved for use in stress cardiac magnetic resonance imaging
14 February 2022 - Already used in single photon emission computed tomography (SPECT) myocardial perfusion imaging for adult patients, Rapiscan is ...