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RSS FeedPosted by Michael Wonder on 01 Feb 2021
Biogen announces FDA approval of Plegridy (peginterferon beta-1a) intramuscular administration for multiple sclerosis
1 February 2021 - Intramuscular injection Plegridy (peginterferon beta-1a) is now approved in the U.S. and the European Union, offering individuals ...
Posted by Michael Wonder on 30 Jan 2021
Phase 1 drug candidate GLR2007 developed by Gan & Lee has been granted fast track designation by the U.S. FDA
29 January 2021 - Gan & Lee Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for GLR2007, ...
Posted by Michael Wonder on 29 Jan 2021
Biogen and Eisai announce FDA's 3 month extension of review period for the biologics license application for aducanumab
29 January 2021 - The new Prescription Drug User Fee Act action date set by the FDA is 7 June ...
Posted by Michael Wonder on 28 Jan 2021
M6P Therapeutics receives six rare paediatric disease designations from the U.S. FDA for company’s deep pipeline of programs for lysosomal storage disorders
28 January 2021 - U.S. FDA also grants two orphan drug designations for the company’s gene therapy programs for Gaucher disease ...
Posted by Michael Wonder on 28 Jan 2021
Bio-Thera Solutions announces FDA accepts biologics license application for BAT1706, a proposed biosimilar to Avastin
28 January 2021 - Bio-Thera Solutions today announced that the U.S. FDA has accepted its biologics license application for BAT1706, a ...
Posted by Michael Wonder on 28 Jan 2021
Advocacy groups urge Biden administration not to tap Woodcock as FDA commissioner
27 January 2021 - As the Biden White House attempts to fashion its health policies, a coalition of consumer and ...
Posted 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 ...