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RSS FeedPosted by Michael Wonder on 09 Apr 2024
Syros receives fast track designation from the FDA for tamibarotene for the treatment of newly diagnosed unfit AML with RARA gene over-expression
9 April 2024 - Syros Pharmaceuticals today announced that the US FDA has granted fast track designation to tamibarotene in ...
Posted by Michael Wonder on 08 Apr 2024
Phanes Therapeutics' PT217 granted fast track designation by the FDA
8 April 2024 - Phanes Therapeutics announced today that the US FDA has granted fast track designation to PT217 for the ...
Posted by Michael Wonder on 03 Apr 2024
RemeGen's telitacicept (RC18) granted fast track designation by US FDA for treatment of primary Sjögren's syndrome
2 April 2024 - RemeGen has obtained fast track designation by the US FDA recently for its innovative BLyS/APRIL dual-target ...
Posted by Michael Wonder on 02 Apr 2024
TME Pharma receives US FDA fast track designation for lead asset NOX-A12 in brain cancer
2 April 2024 - Fast track designation for NOX-A12 follows recently announced FDA clearance of investigational new drug application for Phase ...
Posted by Michael Wonder on 29 Mar 2024
LISCure Biosciences receives US FDA fast track designation for LB-P8 for the treatment of primary sclerosing cholangitis
29 March 2024 - Phase 2 study is underway and LB-P8 is the only live biotherapeutic product currently reported to be ...
Posted by Michael Wonder on 29 Mar 2024
Korean drug for metabolism-related steatohepatitis gets FDA’s fast track designation
28 March 2024 - D&D Pharmatech said Thursday that DD01, an injectable treatment for metabolic-associated steatohepatitis (MASH) being developed by ...
Posted by Michael Wonder on 26 Mar 2024
Johnson & Johnson's nipocalimab granted US FDA fast track designation to reduce the risk of foetal neonatal allo-immune thrombocytopenia in allo-immunised pregnant adults
26 March 2024 - The Phase 3 FREESIA program is underway and nipocalimab is the only investigational therapy currently reported ...
Posted by Michael Wonder on 16 Mar 2024
ImmVira's oncolytic product MVR-T3011 IT intratumoral injection receives FDA fast track designation for HNSCC treatment
15 March 2024 - ImmVira has recently announced that the US FDA has granted fast track designation for oncolytic virus product ...
Posted by Michael Wonder on 14 Mar 2024
Keros Therapeutics announces US FDA fast track designation for KER-050 in lower-risk myelodysplastic syndromes
14 March 2024 - Keros Therapeutics today announced that the US FDA has granted fast track designation for KER-050 (elritercept) for ...
Posted by Michael Wonder on 06 Mar 2024
Trellis Bioscience's TRL1068 receives FDA fast track and QIDP designations, amplifying commitment to combat infectious diseases
6 March 2024 - Trellis Bioscience is thrilled to announce that its lead antibody candidate, TRL1068, has been granted fast ...
Posted by Michael Wonder on 05 Mar 2024
Ellipses' next generation selective RET inhibitor EP0031/A400 granted fast track designation by US FDA
5 March 2024 - Ellipses Pharma announced today that it has received fast track designation from the US FDA for its ...
Posted by Michael Wonder on 29 Feb 2024
Indapta Therapeutics receives US FDA fast track designation for lead clinical drug candidate IDP-023 for non-Hodgkin’s lymphoma and myeloma
29 February 2024 - Highly differentiated allogeneic natural killer cell therapy in Phase 1 trial, with initial data expected in second ...
Posted by Michael Wonder on 28 Feb 2024
FDA grants fast track designation to 9MW2821
27 February 2024 - Mabwell announces that its self developed novel antibody drug conjugate targeting Nectin-4 (9MW2821) has been granted fast ...
Posted by Michael Wonder on 22 Feb 2024
Artiva Biotherapeutics receives FDA fast track designation for AlloNK in lupus nephritis
22 February 2024 - Artiva Biotherapeutics announced today that the US FDA has granted fast track designation to Artiva’s lead ...
Posted by Michael Wonder on 20 Feb 2024
Omnix Medical granted fast track designation by US FDA for its next generation anti-infective OMN6
20 February 2024 - Omnix Medical today announced that the Company has received fast track designation for its novel anti-infective ...