Blog
RSS FeedPosted by Michael Wonder on 04 Aug 2022
Economic evaluation of genomic/genetic tests: a review and future directions
1 August 2022 - It has been suggested that health economists need to improve their methods in order to meet the ...
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 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. ...