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RSS FeedPosted by Michael Wonder on 05 Sep 2023
Abliva’s lead candidate KL1333 receives FDA fast track designation
4 September 2023 - Abliva today announced that the company’s lead candidate KL1333 has received fast track designation from the ...
Posted by Michael Wonder on 24 Aug 2023
Taysha Gene Therapies announces fast track designation granted by US FDA for TSHA-102 in Rett syndrome
24 August 2023 - TSHA-102 has also received orphan drug and rare paediatric disease designations from the US FDA and ...
Posted by Michael Wonder on 24 Aug 2023
Alentis Therapeutics receives FDA fast track designation for ALE.C04 for the treatment of Claudin-1 positive HNSCC
24 August 2023 - Fast Track designation accelerates the path to US submission for the investigational monoclonal antibody in patients with ...
Posted by Michael Wonder on 24 Aug 2023
Nectero Medical receives FDA fast track designation for Nectero EAST System
24 August 2023 - Fast Track designation accelerates Nectero EAST System’s path to FDA regulatory review of a treatment for patients ...
Posted by Michael Wonder on 23 Aug 2023
Comanche Biopharma receives US FDA fast track designation for CBP-4888 for the treatment of sFlt-1 mediated pre-term preeclampsia
23 August 2023 - Comanche Biopharma today announced that they have received fast track designation from the US FDA for ...
Posted by Michael Wonder on 11 Aug 2023
US FDA designates PYC's lead as a fast track development program
11 August 2023 - The Company is currently evaluating the safety/tolerability and efficacy of an investigational drug candidate with disease-modifying potential ...
Posted by Michael Wonder on 02 Aug 2023
PYC Therapeutics gets fast track status from FDA for retinitis pigmentosa treatment
1 August 2023 - PYC Therapeutics has received fast track designation from the US FDA for a new drug aimed ...
Posted by Michael Wonder on 31 Jul 2023
FDA grants fast track designation to IVS-3001, a CAR-T cell therapy in the treatment of renal cell carcinoma
31 July 2023 - Invectys is pleased to announce the US FDA has granted fast track designation to its revolutionary ...
Posted by Michael Wonder on 24 Jul 2023
Astria Therapeutics receives fast track designation for STAR-0215 for the treatment of hereditary angioedema
20 July 2023 - On track for proof of concept results in HAE patients in mid 2024. ...
Posted by Michael Wonder on 21 Jul 2023
Excision BioTherapeutics receives FDA fast track designation for EBT-101, a first in class CRISPR based gene therapy candidate to functionally cure HIV-1
20 July 2023 - EBT-101 is a potentially curative, one time CRISPR based treatment which makes two cuts in integrated retroviral ...
Posted by Michael Wonder on 19 Jul 2023
FDA grants fast track designation for Ambrx’s ARX517 for the treatment of metastatic castration resistant prostate cancer
19 July 2023 - Ambrx Biopharma today announced that the US FDA has granted fast track designation to Ambrx’s proprietary anti-PSMA ...
Posted by Michael Wonder on 17 Jul 2023
Karyopharm receives FDA fast track designation for selinexor for the treatment of myelofibrosis
17 July 2023 - Regulatory designation includes primary myelofibrosis, post-essential thrombocythemia myelofibrosis and post-polycythemia vera myelofibrosis. ...
Posted by Michael Wonder on 12 Jul 2023
Biosyngen's first in class cell therapy BRG01 receives FDA fast track designation
12 July 2023 - On July 6, 2023, Biosyngen received an official notification from the US FDA granting fast track ...
Posted by Michael Wonder on 11 Jul 2023
Synlogic granted fast track designation from FDA for labafenogene marselecobac (SYNB1934) for treatment of phenylketonuria
11 July 2023 - Synlogic today announced that the US FDA has granted fast track designation to labafenogene marselecobac (previously known ...
Posted by Michael Wonder on 06 Jul 2023
Kazia's paxalisib receives fast track designation from FDA for treatment of solid tumour brain metastases harbouring PI3K pathway mutations in combination with radiation therapy
6 July 2023 - Kazia Therapeutics is pleased to announce that its lead program, paxalisib, has been awarded fast track ...