Blog
RSS FeedPosted by Michael Wonder on 02 Oct 2023
Avenge Bio receives FDA fast track designation for AVB-001, a novel cell therapy leveraging the LOCOcyte immunotherapy platform
2 October 2023 - Regulatory designation includes platinum-resistant, high grade serous adenocarcinoma of the ovary, primary peritoneum or fallopian tube. ...
Posted by Michael Wonder on 27 Sep 2023
ABM Therapeutics' ABM-1310 granted fast track designation by the FDA following orphan drug designation
26 September 2023 - ABM Therapeutics is pleased to announce today that the US FDA has granted fast track designation for ...
Posted by Michael Wonder on 27 Sep 2023
IDEAYA receives fast track designation for potential first in class PARG inhibitor, IDE161, for treatment of pretreated, platinum-resistant advanced or metastatic ovarian cancer patients having tumours with BRCA1/2 mutations
26 September 2023 - On-going Phase 1 expansion, with focus in ER positive, HER2 negative, HRD positive breast cancer, HRD positive ...
Posted by Michael Wonder on 27 Sep 2023
Mythic Therapeutics receives FDA fast track designation for MYTX-011 for patients with non-small cell lung cancer with cMET over-expression
26 September 2023 - This designation encompasses non-small-cell lung cancer patients with any level of cMET over-expression, including low and intermediate, ...
Posted by Michael Wonder on 22 Sep 2023
89bio announces US FDA has granted breakthrough therapy designation for pegozafermin in non-alcoholic steatohepatitis
21 September 2023 - Supported by positive data in F2/F3 and F4 NASH patients from the ENLIVEN Phase 2b trial of ...
Posted by Michael Wonder on 21 Sep 2023
Disc Medicine receives FDA fast track designation for MWTX-003 for the treatment of polycythemia vera
20 September 2023 - Disc Medicine today announced that the US FDA has granted fast track designation to MWTX-003 for the ...
Posted by Michael Wonder on 18 Sep 2023
Kymera Therapeutics receives US FDA fast track designation for KT-333, a first in class, investigational STAT3 degrader for the treatment of relapsed/refractory cutaneous T-cell lymphoma and relapsed/refractory peripheral T-cell lymphoma
18 September 2023 - KT-333 Phase 1 oncology trial ongoing with an update including initial evaluation of its clinical anti-tumour activity ...
Posted by Michael Wonder on 12 Sep 2023
MorphoSys receives US FDA fast track designation for tulmimetostat in endometrial cancer
12 September 2023 - Tulmimetostat follows pelabresib (2018) and tafasitamab (2014) as the company’s third clinical program to receive fast ...
Posted by Michael Wonder on 12 Sep 2023
Affimed receives FDA fast track designation for AFM13 in combination with AlloNK for the treatment of patients with relapsed or refractory Hodgkin lymphoma
12 September 2023 - Affimed today announced that the FDA has granted fast track designation to the combination of its innate ...
Posted by Michael Wonder on 08 Sep 2023
Mendus receives US FDA fast track designation for vididencel in acute myeloid leukaemia
8 September 2023 - Mendus today announced that it has received fast track designation from the US FDA for the Company’s ...
Posted 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 ...