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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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. ...

Read more →

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 ...

Read more →

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 ...

Read more →

New drug application resubmission

31 March 2022 - NDA submission for Polarean’s hyperpolarised 129Xenon gas drug device combination product ...

Read more →

Gadopiclenol marketing authorisation dossier submissions accepted for review by EMA and FDA

29 March 2022 - Priority review granted by U.S. FDA. ...

Read more →

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. ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →