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RSS FeedPosted by Michael Wonder on 15 Mar 2021
Calliditas announces submission of new drug application to U.S. FDA for Nefecon in patients with primary IgA nephropathy
15 March 2021 - Calliditas Therapeutics today announced the submission of a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 13 Mar 2021
Marius Pharmaceuticals receives PDUFA date for Kyzatrex NDA for treatment of hypogonadism
11 March 2021 - Marius Pharmaceuticals announced today that the U.S. FDA has assigned a Prescription Drug User Fee Act goal ...
Posted by Michael Wonder on 11 Mar 2021
Revolutionary option for medical device sterilisation approved by FDA
11 March 2021 - The United States FDA newly approved chlorine dioxide gas for contract sterilisation of medical devices. ...
Posted by Michael Wonder on 11 Mar 2021
Berlin Heals receives breakthrough device designation from FDA for its C-MIC heart failure device and initiates early feasibility study in the United States
11 March 2021 - Berlin Heals announced today that the US FDA has granted a breakthrough device designation for its ...
Posted by Michael Wonder on 11 Mar 2021
Denali Therapeutics announces fast track designation granted by the U.S. FDA to ETV:IDS (DNL310) for the treatment of patients with Hunter syndrome
11 March 2021 - Denali Therapeutics today announced that the U.S. FDA has granted fast track designation to ETV:IDS (DNL310) for ...
Posted by Michael Wonder on 11 Mar 2021
FDA grants fast track designation to Spectrum Pharmaceuticals’ poziotinib
11 March 2021 - Spectrum Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for poziotinib for the ...
Posted by Michael Wonder on 11 Mar 2021
FDA grants breakthrough device designation for Inivata’s RaDaR assay
9 March 2021 - Designation will help accelerate the regulatory path of RaDaR for use in detection of minimal residual ...
Posted by Michael Wonder on 11 Mar 2021
Kadmon announces U.S. FDA has extended the review period for belumosudil in chronic graft versus host disease
10 March 2021 - Kadmon today announced that the U.S. FDA has extended the review period for the new drug application ...
Posted by Michael Wonder on 10 Mar 2021
AVEO Oncology announces U.S. FDA approval of Fotivda (tivozanib) for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma
10 March 2021 - AVEO plans to make Fotivda available to patients in the U.S. by 31 March 2021. ...
Posted by Michael Wonder on 10 Mar 2021
Vertex announces FDA fast track designation and initiation of a Phase 1/2 clinical trial for VX-880, a novel investigational cell therapy for the treatment of type 1 diabetes
10 March 2021 - VX-880 is the first investigational stem cell derived therapy utilising fully differentiated, insulin-producing pancreatic islet cells for ...
Posted by Michael Wonder on 10 Mar 2021
FDA accepts the new drug application for review of Idorsia’s daridorexant for the treatment of adult patients with insomnia
10 March 2021 - The application includes robust data from the Phase 3 registration program, which demonstrated efficacy of daridorexant on ...
Posted by Michael Wonder on 10 Mar 2021
U.S. FDA accepts UVision360 submission for novel Luminelle DTx system biopsy sheath
9 March 2021 - UVision360 announces today that the U.S. FDA has accepted the Company's submission to expand the Luminelle DTx ...
Posted by Michael Wonder on 09 Mar 2021
Rocket Pharmaceuticals receives FDA regenerative medicine advanced therapy designation for RP-L201 gene therapy for leukocyte adhesion deficiency-I
9 March 2021 - Enrollment complete in Phase 1/2 clinical trial of RP-L201 for the treatment of LAD-I. ...
Posted by Michael Wonder on 09 Mar 2021
Seqirus announces U.S. FDA approval of expanded age indication of its cell based quadrivalent influenza vaccine for people two years of age and older
5 March 2021 - Seqirus today announced that the U.S. FDA has approved Flucelvax Quadrivalent (influenza vaccine), the company's cell-based quadrivalent ...
Posted by Michael Wonder on 09 Mar 2021
Biden’s silence on an FDA nominee underscores how tough it is to fill that job
9 March 2021 - Nearly everyone here expected President Biden to move with record speed to nominate someone to lead ...