Blog
RSS FeedPosted by Michael Wonder on 18 Jan 2023
FDA’s breakthrough program: faster drug OKs without sacrificing safety
18 January 2023 - A FDA program markedly cut the time and cost of bringing to market new drugs, without ...
Posted by Michael Wonder on 12 Jan 2023
Medcura receives breakthrough device designation for its LifeGel absorbable surgical hemostat
13 January 2023 - Medcura announces that the US FDA has granted the coveted breakthrough device designation for its LifeGel absorbable ...
Posted by Michael Wonder on 11 Jan 2023
Micronoma receives FDA breakthrough device designation for OncobiotaLUNG, a novel liquid biopsy assay for lung carcinoma detection
10 January 2023 - The OncobiotaLUNG assay is the first blood microbiome driven liquid biopsy with proven effectiveness, including identifying cancer ...
Posted by Michael Wonder on 11 Jan 2023
EndoTheia announces FDA breakthrough device designation for technology to improve endoscopic surgery
10 January 2023 - EndoTheia announced today that it has gained priority status from the FDA by receiving a breakthrough ...
Posted by Michael Wonder on 09 Jan 2023
Opticyte earns FDA breakthrough device designation for the first cell O2 patient monitor for organ failure
9 January 2023 - Opticyte leverages proprietary machine learning to non-invasively assess organ dysfunction due to low cellular oxygenation in ...
Posted by Michael Wonder on 06 Jan 2023
Vaxcyte’s VAX-24 granted FDA breakthrough therapy designation for the prevention of invasive pneumococcal disease in adults
5 January 2023 - Breakthrough therapy designation for 24 valent investigational pneumococcal conjugate vaccine candidate based on positive topline proof of ...
Posted by Michael Wonder on 05 Jan 2023
OncoNano Medicine’s pegsitacianine granted breakthrough therapy designation for real-time surgical imaging by the FDA
4 January 2023 - OncoNano Medicine today announced that its lead clinical development candidate, pegsitacianine, a pH sensitive fluorescent nanoprobe ...
Posted by Michael Wonder on 04 Jan 2023
Burning Rock received FDA breakthrough device designation for its OverC multi-cancer detection blood test
3 January 2023 - Burning Rock today announced that its OverC Multi-Cancer Detection Blood Test (MCDBT) has been granted breakthrough device ...
Posted by Michael Wonder on 03 Jan 2023
US FDA grants breakthrough designation for blood test to help diagnose inaccessible brain tumours
2 January 2023 - Datar Cancer Genetics now has three breakthrough designations granted by the US FDA, including liquid biopsies ...
Posted by Michael Wonder on 30 Dec 2022
The FDA’s ‘breakthrough’ program for medical devices keeps gaining steam
28 December 2022 - For medical devices in the Breakthrough Devices Program, 2022 has been a breakout year. ...
Posted by Michael Wonder on 22 Dec 2022
Mirati announces adagrasib (Krazati) receives breakthrough therapy designation from FDA for patients with advanced, KRAS mutated colorectal cancer
21 December 2022 - The US FDA has granted breakthrough therapy designation for adagrasib (Krazati) in combination with cetuximab in ...
Posted by Michael Wonder on 18 Dec 2022
Click Therapeutics receives FDA breakthrough device designation for prescription digital therapeutic to treat episodic migraine
16 December 2022 - Click Therapeutics today announced that it has received breakthrough device designation from the US FDA for ...
Posted by Michael Wonder on 10 Dec 2022
Efruxifermin granted FDA breakthrough therapy designation for NASH
8 December 2022 - Designation based on Akero’s Phase 2b HARMONY study finding that both the 50 mg and 28 mg efruxifermin ...
Posted by Michael Wonder on 06 Dec 2022
Syndax announces US FDA breakthrough therapy designation granted for revumenib for the treatment of adult and paediatric patients with relapsed or refractory KMT2A rearranged acute leukaemia
5 December 2022 - Revumenib is the first and only investigational treatment for R/R KMT2Ar acute leukaemia to receive breakthrough therapy ...
Posted by Michael Wonder on 19 Nov 2022
Iveric Bio announces FDA has granted breakthrough therapy designation for avacincaptad pegol for geographic atrophy
17 November 2022 - Designation based on 12 month primary endpoint data from GATHER pivotal trials. ...