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RSS FeedPosted by Michael Wonder on 27 Aug 2020
Editas Medicine receives rare paediatric disease designation for EDIT-301 for the treatment of sickle cell disease
24 August 2020 - Editas Medicine today announced that the U.S. FDA has granted rare paediatric disease designation for EDIT-301, an ...
Posted by Michael Wonder on 27 Aug 2020
FDA approves Foundation Medicine's FoundationOne Liquid CDx, a comprehensive pan-tumour liquid biopsy test with multiple companion diagnostic indications for patients with advanced cancer
26 August 2020 - FDA approval includes companion diagnostic claims for Rubraca (rucaparib), the first PARP inhibitor approved in a prostate ...
Posted by Michael Wonder on 27 Aug 2020
European Commission approves Blenrep (belantamab mafodotin) for the treatment of patients with relapsed and refractory multiple myeloma
26 August 2020 - Marketing authorisation follows the recent US approval of Blenrep. ...
Posted by Michael Wonder on 27 Aug 2020
The EU Commission grants conditional approval for Idefirix (imlifidase) in highly sensitised kidney transplant patients in the European Union
26 August 2020 - The conditional approval by the European Commission serves as a landmark milestone for Hansa Biopharma, as Idefirix ...
Posted by Michael Wonder on 26 Aug 2020
Developing safe and effective COVID vaccines — Operation Warp speed’s strategy and approach
26 August 2020 - Announced on May 15, Operation Warp Speed— a partnership of the Department of Health and Human ...
Posted by Michael Wonder on 26 Aug 2020
Catalyst takes its fight over a rare disease drug to Canada, suing the country’s regulator
26 August 2020 - In unusual battle between two small companies over the market for a rare disease drug has ...
Posted by Michael Wonder on 26 Aug 2020
FDA chief apologises for overstating plasma effect on virus
26 August 2020 - Food and Drug Administration Commissioner Stephen Hahn is apologising for overstating the life-saving benefits of using convalescent ...
Posted by Michael Wonder on 26 Aug 2020
Cystic fibrosis drug could reduce severe disease, deaths if made available to Canadians
25 August 2020 - Talia D’Alessio has been living with cystic fibrosis since she was nine months old. ...
Posted by Michael Wonder on 26 Aug 2020
Knight and TherapeuticsMD announce Health Canada approval of Imvexxy
25 August 2020 - Knight Therapeutics and TherapeuticsMD announced today the approval of Imvexxy by Health Canada. In Canada, Imvexxy is ...
Posted by Michael Wonder on 26 Aug 2020
Sarepta Therapeutics announces FDA acceptance of casimersen (SRP-4045) new drug application for patients with Duchenne muscular dystrophy amenable to skipping exon 45
25 August 2020 - Received FDA's conditional approval of Amondys 45 as brand name for casimersen. ...
Posted by Michael Wonder on 26 Aug 2020
Metacrine announces MET409 receives FDA fast track designation for the treatment of NASH
25 August 2020 - Metacrine today announced that the U.S. FDA has granted fast track designation to MET409, the company’s lead ...
Posted by Michael Wonder on 25 Aug 2020
FDA accepts filing of new drug application for tepotinib for the treatment of patients with metastatic NSCLC with METex14 skipping alterations
25 August 2020 - Tepotinib granted priority review and is being evaluated under FDA Real-Time Oncology Review pilot program. ...
Posted by Michael Wonder on 25 Aug 2020
F.D.A. ‘grossly misrepresented’ blood plasma data, scientists say
24 August 2020 - Many experts — including a scientist who worked on the Mayo Clinic study — were bewildered about ...
Posted by Michael Wonder on 25 Aug 2020
AbbVie aubmits regulatory application to FDA for Rinvoq (upadacitinib) for the treatment of adults with active ankylosing spondylitis
25 August 2020 - In a pivotal Phase 2/3 study, twice as many patients receiving Rinvoq achieved the primary endpoint of ...
Posted by Michael Wonder on 25 Aug 2020
As COVID-19 pressures mount, political newcomer Stephen Hahn struggles to protect an FDA under siege
24 August 2020 - Stephen Hahn, a political novice who moved here in December to take over the FDA, has ...