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RSS FeedPosted by Michael Wonder on 27 Jan 2021
Alleviant Medical receives breakthrough device designation from FDA for transcatheter technology
25 January 2021 - Alleviant Medical today announced that the US FDA has granted the company a breakthrough device designation ...
Posted by Michael Wonder on 27 Jan 2021
PEDRA Technology receives FDA breakthrough device designation for its PEDRA Xauron real-time tissue perfusion system
25 January 2021 - Novel perfusion monitor achieves FDA breakthrough device Designation for real-time, peri-procedural monitoring of tissue perfusion in patients ...
Posted by Michael Wonder on 26 Jan 2021
MeiraGTx announces AAV-CNGA3 granted fast track designation by U.S. FDA for treatment of achromatopsia
26 January 2021 - MeiraGTx today announced that the U.S. FDA has granted fast track designation to its AAV-CNGA3 gene therapy ...
Posted by Michael Wonder on 26 Jan 2021
Recordati Rare Diseases: Carbaglu (carglumic acid) receives U.S. FDA approval for a new indication to treat acute hyperammonaemia associated with propionic acidemia and methylmalonic acidemia
26 January 2021 - Carbaglu is first and only FDA approved medication for hyperammonaemia associated with these rare conditions. ...
Posted by Michael Wonder on 26 Jan 2021
Vertex announces U.S. FDA acceptance of supplemental new drug application for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 6 through 11 with certain mutations
26 January 2021 - FDA grants priority review of the application and sets a PDUFA target action date of 8 June ...
Posted by Michael Wonder on 26 Jan 2021
FDA approves Theranica's Nerivio for acute treatment of migraine in adolescents
25 January 2021 - Theranica today announced that its Nerivio therapeutic device has received the FDA clearance to market for ...
Posted by Michael Wonder on 26 Jan 2021
Albireo announces U.S. FDA acceptance of new drug application for odevixibat
25 January 2021 - FDA has granted odevixibat fast track, rare paediatric disease and orphan drug designations. ...
Posted by Michael Wonder on 26 Jan 2021
Iterum Therapeutics announces U.S. FDA filing acceptance of new drug application for oral sulopenem
25 January 2021 - If approved, first oral penem in the U.S. and first new oral treatment for uUTIs in over ...
Posted by Michael Wonder on 25 Jan 2021
FDA grants toripalimab fast track designation for mucosal melanoma
25 January 2021 - Junshi Biosciences announced today that U.S. FDA has granted toripalimab fast track designation for the first-line treatment ...
Posted by Michael Wonder on 24 Jan 2021
The stakes for choosing the right FDA commissioner couldn’t be higher
24 January 2021 - An independent, credible, science led Food and Drug Administration has long been vital to America’s public, ...
Posted by Michael Wonder on 23 Jan 2021
FDA approves Aurinia Pharmaceuticals’ Lupkynis (voclosporin) for adult patients with active lupus nephritis
22 January 2021 - Lupkynis is the first FDA approved oral therapy for lupus nephritis, a condition that causes irreversible kidney ...
Posted by Michael Wonder on 22 Jan 2021
ICER publishes evidence report on therapies for high cholesterol
22 January 2021 - The evidence suggests that inclisiran can substantially lower LDL-C with limited safety concerns, and with a ...
Posted by Michael Wonder on 22 Jan 2021
FDA approves nivolumab plus cabozantinib for advanced renal cell carcinoma
22 January 2021 - Today the FDA approved the combination of nivolumab (Opdivo, Bristol-Myers) and cabozantinib (Cabometyx, Exelixis) as ...
Posted by Michael Wonder on 22 Jan 2021
ICER releases draft evidence report on therapies for lupus nephritis
22 January 2021 - Public comment period now open until 18 February 2021; requests to make oral comment during public meeting ...
Posted by Michael Wonder on 22 Jan 2021
Incyte announces acceptance and priority review of BLA for retifanlimab as a potential treatment for patients with squamous cell carcinoma of the anal canal
21 January 2021 - Incyte today announced that the U.S. FDA has accepted for priority review its biologics license application for ...