Blog
RSS FeedPosted by Michael Wonder on 02 Jun 2022
Fast track designation granted to MTX110 development for the treatment of recurrent glioblastoma
1 June 2022 - Midatech Pharma is pleased to announce that upon submitting an application to the U.S. FDA, its development ...
Posted by Michael Wonder on 31 May 2022
Priothera receives fast track designation for mocravimod in combination with allogeneic haematopoietic stem cell transplant for post remission therapy of acute myeloid leukaemia patients
31 May 2022 - Priothera today announces that the U.S. FDA has granted fast track designation for mocravimod in combination with ...
Posted by Michael Wonder on 26 May 2022
Pfizer granted FDA fast track designation for ervogastat/clesacostat combination for the treatment of non-alcoholic steatohepatitis
26 May 2022 - Pfizer today announced the U.S. FDA has granted fast track designation to Pfizer’s investigational combination therapy ...
Posted by Michael Wonder on 25 May 2022
Elevation Oncology announces FDA fast track designation granted to seribantumab for the tumour agnostic treatment of solid tumours harbouring NRG1 gene fusions
25 May 2022 - Elevation Oncology today announced that the U.S. FDA has granted fast track designation to seribantumab for the ...
Posted by Michael Wonder on 24 May 2022
Blue Lake Biotechnology announces FDA fast track designation for BLB-201 intranasal RSV vaccine
24 May 2022 - Blue Lake Biotechnology today announced that the U.S. FDA has granted fast track designation for BLB-201, an ...
Posted by Michael Wonder on 04 May 2022
Aptose receives fast track designation for HM43239 in relapsed/refractory AML patients and FLT3 mutation
4 May 2022 - Aptose Biosciences today announced that the U.S. FDA has granted fast track designation to HM43239, an oral, ...
Posted by Michael Wonder on 04 May 2022
Pliant Therapeutics receives FDA fast track designation for PLN-74809 for the treatment of idiopathic pulmonary fibrosis
3 May 2022 - Pliant Therapeutics announced today that PLN-74809, its oral, dual-selective αvß6/αvß1 integrin inhibitor, has received fast track ...
Posted by Michael Wonder on 04 May 2022
Graphite Bio announces U.S. FDA fast track designation granted to GPH101 for the treatment of sickle cell disease
3 May 2022 - GPH101 is an investigational next-generation gene-edited therapy designed to potentially provide a one time cure for ...
Posted by Michael Wonder on 03 May 2022
Belite Bio receives FDA fast track designation for LBS-008
3 May 2022 - LBS-008 (aka tinlarebant) is the Company’s orally administered tablet for the treatment of Stargardt disease. ...
Posted by Michael Wonder on 02 May 2022
Vaxxinity receives FDA fast track designation for UB-311 for treatment of Alzheimer’s disease
2 May 2022 - Vaxxinity today announced that UB-311, an anti-amyloid beta immunotherapeutic vaccine, has been granted fast track designation by ...
Posted by Michael Wonder on 29 Apr 2022
Timber Pharmaceuticals announces fast track designation granted by FDA for TMB-001 in severe subtypes of congenital ichthyosis
28 April 2022 - Company expects to launch pivotal Phase 3 ASCEND clinical trial to evaluate TMB-001 within the next ...
Posted by Michael Wonder on 28 Apr 2022
SQZ Biotechnologies receives FDA fast track designation for its lead cell therapy candidate for the treatment of HPV16 positive tumours
27 April 2022 - Designation Creates Potential to Bring Important New Therapy to Patients Earlier. ...
Posted by Michael Wonder on 27 Apr 2022
OncoC4 announces fast track designation granted by the U.S. FDA for ONC-392 monotherapy in PD(L)1 resistant NSCLC
26 April 2022 - OncoC4 announced today that the U.S. FDA has granted fast track designation to ONC-392, the Company’s next-gen ...
Posted by Michael Wonder on 26 Apr 2022
Prothena receives FDA fast track designation for PRX012, a next generation anti-amyloid beta antibody under investigation for the treatment of Alzheimer’s disease
26 April 2022 - PRX012 is a potential best in class, subcutaneous anti-amyloid beta antibody therapy currently in a Phase ...
Posted by Michael Wonder on 26 Apr 2022
VBL Therapeutics receives FDA fast track designation for ofra-vec for the treatment of platinum-resistant ovarian cancer
26 April 2022 - OVAL Phase 3 top-line progression-free survival primary outcome data for ofra-vec expected in 2H 2022; with ...