Blog
RSS FeedPosted 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 15 Jun 2022
NICE’s early value assessment for medtech: panning for nuggets of innovation gold
15 June 2022 - The explosion in digital health products has left NHS commissioners wondering how they can possibly sift out ...
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 30 May 2022
Illuccix reimbursement milestone and launch updates: pass-through status granted in the U.S.
30 May 2022 - Telix Pharmaceuticals today provides an update on the U.S. and Australian launch and reimbursement status for ...
Posted by Michael Wonder on 19 May 2022
Draft NICE guidance recommends innovative technology used to establish whether breast cancer has spread
17 May 2022 - A magnetic marker liquid injected into people with invasive breast cancer will help surgeons discover if the ...
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 ...
Posted by Michael Wonder on 14 Feb 2022
US FDA grants the coveted breakthrough designation for early stage prostate cancer detection blood test developed in India by Datar Cancer Genetics
14 February 2022 - It is the first blood test able to detect early stage prostate cancer with high accuracy ...
Posted by Michael Wonder on 04 Feb 2022
Biden-Harris Administration will cover free over the counter COVID-19 tests through Medicare
3 February 2022 - As part of the Biden-Harris Administration’s ongoing efforts to expand Americans’ access to free testing, people in ...