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RSS FeedPosted by Michael Wonder on 08 Jun 2023
Rocket Pharmaceuticals receives FDA fast track and orphan drug designations for RP-A601 gene therapy for PKP2 arrhythmogenic cardiomyopathy
8 June 2023 - Rocket Pharmaceuticals today announced that the US FDA has granted fast track and orphan drug designations ...
Posted by Michael Wonder on 08 Jun 2023
SAR443579/IPH6101 receives FDA fast track designation in the US for the treatment of haematological malignancies
8 June 2023 - SAR443579, ANKET platform lead asset, is a trifunctional anti-CD123 NKp46×CD16 NK cell engager from a joint research ...
Posted by Michael Wonder on 01 Jun 2023
Arcturus Therapeutics receives US FDA fast track designation for ARCT-810, mRNA therapeutic candidate for ornithine transcarbamylase deficiency
1 June 2023 - Arcturus Therapeutics today announced that the US FDA has granted fast track designation to ARCT-810, the Company’s ...
Posted by Michael Wonder on 30 May 2023
Inhibrx granted fast track designation for INBRX-101 for the treatment of alfa-1 antitrypsin deficiency
30 May 2023 - Inhibrx announced today that the US FDA granted fast track designation to INBRX-101, an optimised recombinant ...
Posted by Michael Wonder on 25 May 2023
Milvexian granted US FDA fast track designation for all three indications under evaluation in Phase 3 Librexia program: ischaemic stroke, acute coronary syndrome and atrial fibrillation
25 May 2023 - The Librexia program evaluating milvexian is unrivaled as the most comprehensive factor XIa inhibitor clinical development ...
Posted by Michael Wonder on 23 May 2023
Centessa Pharmaceuticals receives fast track designation from the US FDA for SerpinPC for haemophilia B
22 May 2023 - Centessa Pharmaceuticals today announced that the US FDA has granted fast track designation to SerpinPC, an ...
Posted by Michael Wonder on 22 May 2023
Sangamo Therapeutics receives US FDA fast track designation for isaralgagene civaparvovec for the treatment of Fabry disease
22 May 2023 - Sangamo Therapeutics today announced that the US FDA has granted fast track designation to isaralgagene civaparvovec, or ...
Posted by Michael Wonder on 17 May 2023
Lumen Bioscience receives fast track designation from US FDA for LMN-201
17 May 2023 - Orally delivered biologic drug for treatment and prevention of C. difficile infection. ...
Posted by Michael Wonder on 17 May 2023
Bayer receives US FDA fast track designation for asundexian atrial fibrillation program
16 May 2023 - The OCEANIC-AF (atrial fibrillation) study with asundexian is part of the Phase III OCEANIC clinical trial program ...
Posted by Michael Wonder on 15 May 2023
ImmPACT Bio granted FDA fast track designation for IMPT-314 in patients with relapsed or refractory aggressive B-cell lymphoma
15 May 2023 - Bispecific CD19/CD20 CAR T therapy demonstrated unmatched safety and durability in UCLA-led Phase 1 study. ...
Posted by Michael Wonder on 10 May 2023
Acrivon Therapeutics announces FDA grants fast track designation for development of ACR-368 in platinum-resistant ovarian cancer and endometrial cancer
9 May 2023 - In previous Phase 2 clinical trials involving more than 400 patients, ACR-368 produced deep, durable monotherapy ...
Posted by Michael Wonder on 03 May 2023
Memo Therapeutics receives FDA fast track designation for AntiBKV as treatment of BKV infection in renal transplant patients
2 May 2023 - Memo Therapeutics announced today that the US FDA has granted fast track designation to AntiBKV, MTx’s ...
Posted by Michael Wonder on 02 May 2023
Erasca granted FDA fast track designation for CNS penetrant EGFR inhibitor ERAS-801 in patients with glioblastoma
1 May 2023 - Erasca today announced the United States FDA has granted fast track designation to ERAS-801 for the treatment ...
Posted by Michael Wonder on 02 May 2023
Cabaletta Bio receives FDA fast track designation for CABA-201
1 May 2023 - Cabaletta Bio today announced that the US FDA has granted fast track designation for CABA-201, a 4-1BB-containing ...
Posted by Michael Wonder on 26 Apr 2023
Atea Pharmaceuticals announces US FDA fast track designation granted to bemnifosbuvir, an investigational oral anti-viral, for the treatment of COVID-19
25 April 2023 - Atea Pharmaceuticals today announced that the United States FDA has granted fast track designation to bemnifosbuvir for ...