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RSS FeedPosted by Michael Wonder on 20 Jan 2026
Ouro Medicines receives US FDA fast track designation for gamgertamig in immune thrombocytopenia and auto-immune haemolytic anaemia
20 January 2026 - Ouro Medicines today announced that gamgertamig (OM336), the company's BCMAxCD3 T cell engager antibody investigational candidate, has ...
Posted by Michael Wonder on 09 Jan 2026
VectorY Therapeutics receives FDA fast track designation for VTx-002, a first in class vectorised antibody targeting underlying disease biology in ALS
8 January 2026 - VectorY Therapeutics announced today that the US FDA has granted fast track designation for VTx-002, a first-in-class ...
Posted by Michael Wonder on 09 Jan 2026
858 Therapeutics announces FDA fast track designation for PARG inhibitor ETX-19477 for the treatment of patients with BRCA mutated, platinum resistant ovarian cancer
8 January 2026 - 858 Therapeutics today announced that the US FDA has granted fast track designation to ETX-19477, the company’s ...
Posted by Michael Wonder on 09 Jan 2026
Alessa Therapeutics announces FDA fast track designation for Enolen, a first of its kind treatment for localised prostate cancer
8 January 2026 - Alessa Therapeutics today announced that the US FDA has granted fast track designation for Enolen, the ...
Posted by Michael Wonder on 09 Jan 2026
Complement Therapeutics announces FDA fast track designation for CTx001 for the treatment of geographic atrophy secondary to AMD
8 January 2025 - Complement Therapeutics today announced that the US FDA has granted fast track designation for CTx001, the company's ...
Posted by Michael Wonder on 05 Jan 2026
Protara Therapeutics receives both FDA breakthrough therapy and fast track designations for TARA-002 in paediatric patients with lymphatic malformations
5 January 2026 - Protara Therapeutics today announced that the US FDA has granted both breakthrough therapy and fast track designations ...
Posted by Michael Wonder on 05 Jan 2026
MapLight Therapeutics receives fast track designation for ML-007C-MA for Alzheimer’s disease psychosis
5 January 2026 - MapLight Therapeutics today announced that the US FDA has granted fast track designation to ML-007C-MA, an investigational ...
Posted 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 ...