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RSS FeedPosted by Michael Wonder on 23 Dec 2025
Invivyd earns fast track designation for VYD2311, a vaccine alternative antibody to prevent COVID
23 December 2025 - Invivyd today announced that the US FDA has granted fast track designation for VYD2311, an investigational vaccine ...
Posted by Michael Wonder on 19 Dec 2025
BeOne Medicines granted US FDA fast track designation for BGB-B2033 as treatment for hepatocellular carcinoma
18 December 2025 - BGB-B2033 is a bispecific antibody directed at GPC3 and 4-1BB; key targets in the most common liver ...
Posted by Michael Wonder on 16 Dec 2025
Palvella Therapeutics granted FDA fast track designation for Qtorin 3.9% rapamycin anhydrous gel for the treatment of angiokeratomas
16 December 2025 - Angiokeratomas are characterised by lymphatic-derived skin lesions that can persistently bleed and significantly impact quality of ...
Posted by Michael Wonder on 16 Dec 2025
Adagene announces FDA fast track designation for muzastotug (ADG126)
16 December 2025 - Adagene today announced that the US FDA has designated muzastotug, in combination with Merck’s anti-PD-1 therapy, Keytruda ...
Posted by Michael Wonder on 11 Dec 2025
Kymera Therapeutics announces US FDA fast track designation for KT-621, a first in class, oral STAT6 degrader for the treatment of atopic dermatitis
11 December 2025 - Fast track designation supported by positive results from the KT-621 BroADen Phase 1b atopic dermatitis patient trial. ...
Posted by Michael Wonder on 04 Dec 2025
Hope Medicine's HMI-115 received US FDA fast track designation, accelerating global development
4 December 2025 - Hope Medicine today announced that its lead pipeline product, HMI-115, a monoclonal antibody targeting the prolactin receptor, ...
Posted by Michael Wonder on 04 Dec 2025
Incannex granted FDA fast track designation for IHL-42X in obstructive sleep apnea
3 December 2025 - Incannex Healthcare announces that the US FDA has granted fast track designation for IHL-42X, the Company’s ...
Posted by Michael Wonder on 03 Dec 2025
Sangamo Therapeutics receives US FDA fast track designation for ST-503 for the treatment of small fibre neuropathy
2 December 2025 - Sangamo Therapeutics today announced that the US FDA has granted fast track designation to ST-503, an investigational ...
Posted by Michael Wonder on 02 Dec 2025
Merck granted fast track designation by the US FDA for MK-2214 for the treatment of Alzheimer's disease
1 December 2025 - MK-2214, an investigational novel antibody targeting phosphorylated serine 413 (pS413) tau. ...
Posted by Michael Wonder on 01 Dec 2025
Cullinan Therapeutics receives FDA fast track designation for CLN-049, a novel FLT3xCD3 T cell engager, in relapsed/refractory acute myeloid leukemia
1 December 2025 - Cullinan Therapeutics today announced that the US FDA has granted fast track designation to CLN-049 for ...
Posted by Michael Wonder on 26 Nov 2025
FDA grants fast track designation to Cothera Bioscience’s zotiraciclib for treatment of recurrent high grade glioma with IDH1/2 mutations
26 November 2025 - Cothera Bioscience today announced that the US FDA has granted fast track designation to zotiraciclib (ZTR/TG02) for ...
Posted by Michael Wonder on 25 Nov 2025
Avenzo Therapeutics granted fast track designation for AVZO-103, a potential best in class nectin4/TROP2 bispecific antibody drug conjugate, for the treatment of patients with urothelial cancer previously treated with enfortumab vedotin
24 November 2025 - Avenzo Therapeutics today announced the US FDA granted fast track designation to AVZO-103, a potential best ...
Posted by Michael Wonder on 24 Nov 2025
Merck takes patient-directed approach to bring innovation to the treatment of rare neuromuscular disorder, generalised myasthenia gravis
24 November 2025 - Merck today announced the FDA has granted fast track designation for cladribine capsules for the treatment of generalised ...
Posted by Michael Wonder on 18 Nov 2025
Vasa Therapeutics granted FDA fast track designation for VS-041, a novel investigational treatment of heart failure with preserved ejection fraction
18 November 2025 - Vasa Therapeutics today announced that the US FDA has granted fast track designation to its lead investigational ...
Posted by Michael Wonder on 17 Nov 2025
FDA grants fast track designation to Dewpoint Therapeutics’ DPTX3186 for the treatment of gastric cancer
17 November 2025 - Dewpoint Therapeutics announced today that the US FDA has granted fast track designation to DPTX3186, the company’s ...