25 January 2021 - Alleviant Medical today announced that the US FDA has granted the company a breakthrough device designation ...
25 January 2021 - Novel perfusion monitor achieves FDA breakthrough device Designation for real-time, peri-procedural monitoring of tissue perfusion in patients ...
26 January 2021 - MeiraGTx today announced that the U.S. FDA has granted fast track designation to its AAV-CNGA3 gene therapy ...
26 January 2021 - Carbaglu is first and only FDA approved medication for hyperammonaemia associated with these rare conditions. ...
26 January 2021 - FDA grants priority review of the application and sets a PDUFA target action date of 8 June ...
25 January 2021 - Theranica today announced that its Nerivio therapeutic device has received the FDA clearance to market for ...
25 January 2021 - FDA has granted odevixibat fast track, rare paediatric disease and orphan drug designations. ...
25 January 2021 - If approved, first oral penem in the U.S. and first new oral treatment for uUTIs in over ...
25 January 2021 - Junshi Biosciences announced today that U.S. FDA has granted toripalimab fast track designation for the first-line treatment ...
24 January 2021 - An independent, credible, science led Food and Drug Administration has long been vital to America’s public, ...
22 January 2021 - Lupkynis is the first FDA approved oral therapy for lupus nephritis, a condition that causes irreversible kidney ...
22 January 2021 - The evidence suggests that inclisiran can substantially lower LDL-C with limited safety concerns, and with a ...
22 January 2021 - Today the FDA approved the combination of nivolumab (Opdivo, Bristol-Myers) and cabozantinib (Cabometyx, Exelixis) as ...
22 January 2021 - Public comment period now open until 18 February 2021; requests to make oral comment during public meeting ...
21 January 2021 - Incyte today announced that the U.S. FDA has accepted for priority review its biologics license application for ...