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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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, ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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