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RSS FeedPosted by Michael Wonder on 22 May 2026
FDA approves new Guardant360 Liquid CDx, the largest FDA approved liquid biopsy panel with a 100x expanded footprint
20 May 2026 - Guardant Health today announced that the US FDA has approved Guardant360 Liquid CDx, advancing blood-based comprehensive genomic ...
Posted by Michael Wonder on 06 May 2026
Guardant Health receives FDA approval for Guardant360 CDx as a companion diagnostic for Arvinas and Pfizer’s Veppanu (vepdegestrant) for patients with ER+/HER2- advanced breast cancer with ESR1 mutations
4 May 2026 - Guardant Health today announced that the US FDA has approved the Guardant360 CDx liquid biopsy test ...
Posted by Michael Wonder on 23 Apr 2026
Labcorp launches FDA approved companion diagnostic to identify patients with ovarian cancer eligible for Keytruda
22 April 2026 - Labcorp today announced the nationwide availability of Agilent Technologies' PD-L1 IHC 22C3 pharmDx, the only companion ...
Posted by Michael Wonder on 10 Apr 2026
FDA accepts NDA for TLX101-Px (Pixclara)
10 April 2026 - Telix today announces that the US FDA has accepted the Company’s resubmitted new drug application for TLX101-Px, ...
Posted by Michael Wonder on 18 Mar 2026
FluoGuide receives FDA fast track designation for FG001 in high grade glioma
18 March 2026 - FluoGuide announces that the US FDA has granted fast track designation to FG001 as an intra-operative imaging ...
Posted by Michael Wonder on 16 Mar 2026
Telix resubmits NDA to US FDA for TLX101-Px (Pixclara) brain cancer imaging candidate
16 March 2026 - Telix Pharmaceuticals today announces the resubmission of a new drug application to the US FDA for ...
Posted by Michael Wonder on 07 Mar 2026
Lantheus announces FDA approval of Pylarify TruVu (piflufolastat F 18) injection
6 March 2026 - Pylarify TruVu is expected to launch in Q4, 2026, with a phased geographic rollout to support a ...
Posted by Michael Wonder on 12 Feb 2026
99mTc-maraciclatide granted FDA fast track designation for the visualisation of inflammation in interstitial lung disease
12 February 2026 - Serac Healthcare announced today that the US FDA has granted fast track designation to 99mTc-maraciclatide as ...
Posted by Michael Wonder on 04 Dec 2025
FDA approves IsoPSA - Cleveland Diagnostics’ novel blood based prostate cancer test
1 December 2025 - Cleveland Diagnostics announced today that the US FDA has approved the company’s IsoPSA in vitro diagnostic ...
Posted by Michael Wonder on 16 Nov 2025
Ascelia Pharma announces FDA acceptance of Orviglance new drug application for review
15 November 2025 - Ascelia Pharma today announced that the US FDA has accepted the new drug application for Orviglance for ...
Posted by Michael Wonder on 29 Oct 2025
Enigma Biomedical USA announces FDA acceptance of new drug application for florquinitau F-18 (MK-6240), a tau PET Alzheimer’s disease radiodiagnostic
28 October 2025 - Enigma Biomedical today announced that the FDA has accepted a new drug application for MK-6240 (florquinitau F-18), ...
Posted by Michael Wonder on 25 Oct 2025
Agitated Solutions receives fast track designation for investigational drug ASI-02
23 October 2025 - ASI-02 is a novel contrast agent for cardiac bubble studies. ...
Posted by Michael Wonder on 19 Oct 2025
Azurity Pharmaceuticals announces the FDA approval of Ferabright (ferumoxytol injection), the first and only iron-based contrast agent indicated for magnetic resonance imaging of the brain
17 October 2025 - Azurity Pharmaceuticals announced today that the US FDA has approved Ferabright (ferumoxytol injection), the first and only ...
Posted by Michael Wonder on 15 Oct 2025
Roche's Elecsys pTau181 becomes the only FDA cleared blood test for use in primary care to rule out Alzheimer's related amyloid pathology
13 October 2025 - Roche today announced that the US FDA has cleared its Elecsys pTau181 test, the only blood ...
Posted by Michael Wonder on 28 Aug 2025
Telix provides regulatory update on TLX250-CDx
28 August 2025 - Telix Pharmaceuticals today announces that it has received a complete response letter from the US FDA ...