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RSS FeedPosted by Michael Wonder on 28 Jul 2021
U.S. FDA grants breakthrough therapy designation to Takeda’s investigational compound, TAK-994, an oral orexin agonist in clinical development for narcolepsy Type 1
29 July 2021 - If approved, investigational TAK-994 may provide a future treatment option targeting the orexin deficiency underlying narcolepsy ...
Posted by Michael Wonder on 26 Jul 2021
Evren Technologies receives FDA breakthrough device designation for the Phoenix
21 July 2021 - Evren Technologies announced today that its non-invasive Phoenix earbud device received Breakthrough Device Designation from the ...
Posted by Michael Wonder on 21 Jul 2021
Venetoclax (Venclexta) granted US FDA breakthrough therapy designation in higher risk myelodysplastic syndrome
21 July 2021 - This is the sixth breakthrough therapy designation granted for venetoclax as AbbVie continues to show ongoing commitment ...
Posted by Michael Wonder on 20 Jul 2021
NeuroMetrix receives FDA breakthrough device designation for treatment of fibromyalgia with its wearable neurostimulation technology
20 July 2021 - NeuroMetrix today announced that its Quell device has received breakthrough designation from the U.S. FDA for treating ...
Posted by Michael Wonder on 19 Jul 2021
Endologix receives FDA breakthrough device designation for ChEVAS system
19 July 2021 - Investigational EVAS system designed for patients with complex abdominal aortic aneurysm. ...
Posted by Michael Wonder on 14 Jul 2021
ASP3772 receives FDA breakthrough therapy designation
12 July 2021 - The U.S. FDA has granted breakthrough therapy designation for ASP3772 for the prevention of pneumonia and invasive ...
Posted by Michael Wonder on 07 Jul 2021
Hyalex Orthopaedics receives FDA breakthrough device designation for novel Hyalex cartilage system
7 July 2021 - Hyalex Orthopaedics announced that the Hyalex Cartilage System has been granted breakthrough device designation from the U.S. ...
Posted by Michael Wonder on 07 Jul 2021
Valneva awarded FDA breakthrough designation for its single-shot Chikungunya vaccine candidate
7 July 2021 - This new U.S. milestone follows FDA fast track and EMA PRIME designations. ...
Posted by Michael Wonder on 01 Jul 2021
Neuroelectrics granted FDA breakthrough device designation for new therapeutic neuromodulation platform to treat refractory focal epilepsy
30 June 2021 - In a pilot study treating refractory epilepsy with Neuroelectrics’ Starstim platform, patients experienced a 44% median ...
Posted by Michael Wonder on 29 Jun 2021
Neuros Medical receives FDA breakthrough device designation for its novel Altius high frequency nerve block system
29 June 2021 - Neuros Medical announced today that it has received Breakthrough Device Designation from the U.S. FDA for the ...
Posted by Michael Wonder on 28 Jun 2021
InnoCare announces breakthrough therapy designation of orelabrutinib by US FDA for treatment of relapsed or refractory mantle cell lymphoma
28 June 2021 - InnoCare Pharma announced today that the U.S. FDA has granted breakthrough therapy designation to its Bruton's ...
Posted by Michael Wonder on 26 Jun 2021
Mirati Therapeutics' adagrasib receives breakthrough therapy designation from U.S. FDA for patients with advanced non-small cell lung cancer harbouring the KRASG12C mutation
24 June 2021 - Mirati Therapeutics announced today that the U.S. FDA has granted breakthrough therapy designation to adagrasib for ...
Posted by Michael Wonder on 24 Jun 2021
Lilly's donanemab receives U.S. FDA's breakthrough therapy designation for treatment of Alzheimer's disease
24 June 2021 - The U.S. FDA granted breakthrough therapy designation for donanemab, Eli Lilly's investigational antibody therapy for Alzheimer's ...
Posted by Michael Wonder on 24 Jun 2021
Eisai and Biogen announce U.S. FDA grants breakthrough therapy designation for lecanemab (BAN2401), an anti-amyloid beta antibody for the treatment of Alzheimer's disease
24 June 2021 - Eisai and Biogen today announced that the U.S. FDA has granted breakthrough therapy designation for lecanemab (BAN2401), ...
Posted by Michael Wonder on 21 Jun 2021
Sensome receives FDA breakthrough device designation for its AI powered stroke guidewire
21 June 2021 - Sensome announced today that it has been granted a Breakthrough Device designation by the Center of Devices ...