Blog
RSS FeedPosted by Michael Wonder on 04 Oct 2022
Cue Biopharma granted FDA fast track designation for CUE-101 for the treatment of recurrent/metastatic head and neck squamous cell carcinoma
4 October 2022 - Cue Biopharma announced today that the U.S. FDA has granted fast track designation to CUE-101, its ...
Posted by Michael Wonder on 03 Oct 2022
Viewpoint Molecular Targeting announces VMT-alfa-NET granted US FDA fast track destination for the treatment of neuroendocrine tumours
3 October 2022 - Viewpoint Molecular Targeting today announced that the US FDA has granted fast track designation for the development ...
Posted by Michael Wonder on 03 Oct 2022
Calithera receives FDA fast track designation for sapanisertib for the treatment of NRF2 mutated squamous lung cancer
3 October 2022 - Enrollment on-going in Phase 2 study evaluating sapanisertib, a dual mTORC1/2 inhibitor, in patients with squamous ...
Posted by Michael Wonder on 29 Sep 2022
Fore Biotherapeutics announces fast track designation granted by FDA to FORE8394 for the treatment of cancers harbouring BRAF class 1 and class 2 alterations
28 September 2022 - FORE8934 currently being evaluated in Phase 1/2a trial for the treatment of advanced solid and CNS tumours ...
Posted by Michael Wonder on 27 Sep 2022
Ayala Pharmaceuticals announces fast track designation granted by US FDA for AL102 in progressing desmoid tumours
27 September 202 - Ayala Pharmaceuticals today announced that the US FDA has granted fast track designation for AL102 for the ...
Posted by Michael Wonder on 26 Sep 2022
Atea Pharmaceuticals announces U.S. FDA fast track designation granted to AT-752 for treatment of dengue
26 September 2022 - AT-752 is a novel, orally administered, direct-acting antiviral in Phase 2 development for treatment of dengue, showing ...
Posted by Michael Wonder on 23 Sep 2022
Kinnate Biopharma receives fast track designation from the US Food and Drug Administration for KIN-2787, an investigational pan-RAF inhibitor
21 September 2022 - Kinnate Biopharma today announced that the US FDA has granted Fast Track designation for Kinnate’s investigational ...
Posted by Michael Wonder on 15 Sep 2022
Jasper Therapeutics announces FDA fast track designation for JSP191, a novel monoclonal antibody targeting CD117, in the treatment of patients with severe combined immunodeficiency undergoing allogeneic haematopoietic stem cell transplantation
15 September 2022 - JSP191 is currently being evaluated in four on-going clinical studies in allogeneic haematopoietic stem cell transplant in ...
Posted by Michael Wonder on 14 Sep 2022
TRACON Pharmaceuticals announces fast track designation by the FDA for envafolimab for the treatment of the soft tissue sarcoma subtypes of UPS and MFS
14 September 2022 - TRACON Pharmaceuticals announced today that the US FDA has granted fast track designation for the development of ...
Posted by Michael Wonder on 14 Sep 2022
aTyr Pharma receives FDA fast track designation for efzofitimod for treatment of systemic sclerosis-associated interstitial lung disease
13 September 2022 - Second fast track designation for efzofitimod clinical program. ...
Posted by Michael Wonder on 13 Sep 2022
Anthos Therapeutics announces that abelacimab has received FDA fast track designation for the prevention of stroke and systemic embolism in patients with atrial fibrillation
8 September 2022 - This is the second fast track designation issued by the FDA for abelacimab. ...
Posted by Michael Wonder on 12 Sep 2022
Mersana Therapeutics announces FDA fast track designation granted to XMT-1660 for the treatment of triple negative breast cancer
12 September 2022 - XMT-1660 currently being studied in a Phase 1 trial enrolling patients with breast, endometrial and ovarian cancers. ...
Posted by Michael Wonder on 08 Sep 2022
Silence Therapeutics announces FDA fast track designation for SLN124, a novel investigational siRNA therapy for the treatment of polycythemia vera
8 September 2022 - Designation provides potential for expedited drug development path. ...
Posted by Michael Wonder on 07 Sep 2022
AmMax Bio announces AMB-05X granted FDA fast track designation for the treatment of tenosynovial giant cell tumour
7 September 2022 - Proof of concept established in Phase 2 Trial of TGCT, with positive efficacy results across multiple clinical ...
Posted by Michael Wonder on 31 Aug 2022
US FDA grants fast track designation for Longeveron’s Lomecel-B product for treatment of hypoplastic left heart syndrome in infants
31 August 2022 - New designation may expedite FDA review and potential approval to address this life-threatening heart condition affecting ...