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RSS FeedPosted by Michael Wonder on 02 Mar 2023
FDA accepts for priority review ADX-2191 new drug application for the treatment of primary vitreoretinal lymphoma
2 March 2023 - PDUFA date is 21 June 2023. ...
Posted by Michael Wonder on 23 Feb 2023
Aflibercept 8 mg BLA for treatment of wet age-related macular degeneration and diabetic macular oedema accepted for FDA priority review
23 February 2023 - BLA supported by two pivotal trials demonstrating non-inferior vision gains to Eylea (aflibercept) Injection, with vast majority ...
Posted by Michael Wonder on 21 Feb 2023
US FDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
21 February 2023 - US FDA has set an action date for August 2023. ...
Posted by Michael Wonder on 21 Feb 2023
Pozelimab (C5 antibody) BLA for treatment of children and adults with ultra-rare CHAPLE disease accepted for FDA priority review
21 February 2023 - If approved, pozelimab would be the first and only treatment for those living with CHAPLE. ...
Posted by Michael Wonder on 20 Feb 2023
Azafaros receives additional regulatory designations for AZ-3102 from FDA, EMA and MHRA
20 February 2023 - Azafaros today announced its progress in on-going interactions with health authorities regarding its lead asset, AZ-3102. ...
Posted by Michael Wonder on 20 Feb 2023
FDA accepts Valneva’s chikungunya vaccine license application for priority review
20 February 2023 - Valneva today announced that the US FDA has completed a filing review of its biologics license ...
Posted by Michael Wonder on 17 Feb 2023
US FDA accepts for priority review the supplemental new drug application for Merck’s Prevymis for prophylaxis of cytomegalovirus disease in kidney transplant recipients at high risk
17 February 2023 - FDA also accepts a separate supplemental application to extend prophylaxis with Prevymis to 200 days in ...
Posted by Michael Wonder on 17 Feb 2023
Iveric Bio announces FDA accepts new drug application and grants priority review for avacincaptad pegol for the treatment of geographic atrophy
16 February 2023 - PDUFA goal date is 19 August 2023. ...
Posted by Michael Wonder on 14 Feb 2023
FDA grants 15 June 2023 PDUFA date to Albireo for Bylvay in Alagille syndrome
14 February 2023 - ASSERT study demonstrated efficacy of Bylvay in pruritus, bile acids and sleep with a low drug-related diarrhoea ...
Posted by Michael Wonder on 13 Feb 2023
IASO Bio announces CT103A granted regenerative medicine advanced therapy and fast track designations by the FDA
12 February 2023 - IASO Biotherapeutics today announced that the US FDA has granted both regenerative medicine advanced therapy designation ...
Posted by Michael Wonder on 09 Feb 2023
FDA grants regenerative medicine advanced therapy designation for rexlemestrocel-L in chronic low back oain
9 February 2023 - Mesoblast today announced that the US FDA's Office of Tissues and Advanced Therapies has granted regenerative ...
Posted by Michael Wonder on 07 Feb 2023
Rocket Pharmaceuticals receives FDA regenerative medicine advanced therapy designation for RP-A501 gene therapy for Danon disease
7 February 2023 - Rocket Pharmaceuticals today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 06 Feb 2023
Sage Therapeutics and Biogen announce FDA accepts filing of new drug application and grants priority review of zuranolone in the treatment of major depressive disorder and post-partum depression
6 February 2023 - Zuranolone is being evaluated as a potential 14 day, rapid acting, once daily, oral medication to treat ...
Posted by Michael Wonder on 01 Feb 2023
FLAG Therapeutics receives rare paediatric disease designation for FLAG-003 for the treatment of children with diffuse intrinsic pontine glioma
31 January 2023 - FLAG Therapeutics announced today that FLAG-003, an investigational small molecule therapy for the treatment of diffuse intrinsic ...
Posted by Michael Wonder on 26 Jan 2023
DiscGenics announces FDA regenerative medicine advanced therapy designation granted to IDCT for degenerative disc disease
26 January 2023 - DiscGenics today announced the US FDA granted regenerative medicine advanced therapy designation to injectable disc cell ...