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RSS FeedPosted 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. ...
Posted by Michael Wonder on 04 Nov 2022
AVITA Medical announces FDA breakthrough device designations for the Recell system
3 November 2022 - AVITA Medical announced today that the FDA granted the Recell system designations as a breakthrough device for ...
Posted by Michael Wonder on 03 Nov 2022
Rhythm Pharmaceuticals announces setmelanotide granted breakthrough therapy designation for hypothalamic obesity by the US FDA
1 November 2022 - Rhythm Pharmaceuticals today announced that setmelanotide received breakthrough therapy designation from the US FDA for the treatment ...
Posted by Michael Wonder on 03 Nov 2022
Pfizer’s elranatamab granted FDA breakthrough therapy designation for relapsed or refractory multiple myeloma
3 November 2022 - Breakthrough therapy designation based on updated data from Phase 2 MagnetisMM-3 study that showed an overall response ...
Posted by Michael Wonder on 26 Oct 2022
CorVista Health receives breakthrough device designation for the CorVista system
25 October 2022 - CorVista Health announces that the US FDA has granted breakthrough device designation for the CorVista System as ...
Posted by Michael Wonder on 25 Oct 2022
EndoStim receives FDA breakthrough device designation for the EndoStim system for the treatment of drug refractory GERD
25 October 2022 - EndoStim announced today that the US FDA granted breakthrough device designation for the Company’s EndoStim system. ...
Posted by Michael Wonder on 21 Oct 2022
Akeso's ivonescimab granted breakthrough therapy designation by China NMPA for the treatment of advanced NSCLC
20 October 2022 - Akeso announced that the Center for Drug Evaluation of China NMPA has granted breakthrough therapy designation ...
Posted by Michael Wonder on 20 Oct 2022
Sinaptica Therapeutics announces FDA breakthrough device designation for its novel non-invasive neurostimulation treatment for Alzheimer’s disease
19 October 2022 - Breakthrough designation is based on positive outcomes from a Phase 2 clinical trial in mild to ...
Posted by Michael Wonder on 18 Oct 2022
Axoft brain implant technology is granted FDA breakthrough device designation
18 October 2022 - Axoft today launched and announced FDA breakthrough device designation for its brain-machine interface to better treat ...
Posted by Michael Wonder on 12 Oct 2022
FDA will begin accepting breakthrough devices for TAP pilot in 2023
11 October 2022 - The US FDA will start accepting products into its total product lifecycle advisory program (TAP) pilot starting ...
Posted by Michael Wonder on 07 Oct 2022
Desktop Health receives FDA clearance for SmileGuard resin for durable and comfortable orthodontic and dental appliances
6 October 2022 - Dentists and labs can use proprietary SmileGuard resin to 3D print bite splints, night guards, and mouth ...
Posted by Michael Wonder on 20 Sep 2022
XVIVO granted breakthrough device designation from the FDA for the liver assist device
20 September 2022 - XVIVO Perfusion has been granted breakthrough device designation from the US FDA for their liver assist device, ...