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RSS FeedPosted by Michael Wonder on 17 May 2023
Lumen Bioscience receives fast track designation from US FDA for LMN-201
17 May 2023 - Orally delivered biologic drug for treatment and prevention of C. difficile infection. ...
Posted by Michael Wonder on 17 May 2023
Bayer receives US FDA fast track designation for asundexian atrial fibrillation program
16 May 2023 - The OCEANIC-AF (atrial fibrillation) study with asundexian is part of the Phase III OCEANIC clinical trial program ...
Posted by Michael Wonder on 15 May 2023
ImmPACT Bio granted FDA fast track designation for IMPT-314 in patients with relapsed or refractory aggressive B-cell lymphoma
15 May 2023 - Bispecific CD19/CD20 CAR T therapy demonstrated unmatched safety and durability in UCLA-led Phase 1 study. ...
Posted by Michael Wonder on 10 May 2023
Acrivon Therapeutics announces FDA grants fast track designation for development of ACR-368 in platinum-resistant ovarian cancer and endometrial cancer
9 May 2023 - In previous Phase 2 clinical trials involving more than 400 patients, ACR-368 produced deep, durable monotherapy ...
Posted by Michael Wonder on 03 May 2023
Memo Therapeutics receives FDA fast track designation for AntiBKV as treatment of BKV infection in renal transplant patients
2 May 2023 - Memo Therapeutics announced today that the US FDA has granted fast track designation to AntiBKV, MTx’s ...
Posted by Michael Wonder on 02 May 2023
Erasca granted FDA fast track designation for CNS penetrant EGFR inhibitor ERAS-801 in patients with glioblastoma
1 May 2023 - Erasca today announced the United States FDA has granted fast track designation to ERAS-801 for the treatment ...
Posted by Michael Wonder on 02 May 2023
Cabaletta Bio receives FDA fast track designation for CABA-201
1 May 2023 - Cabaletta Bio today announced that the US FDA has granted fast track designation for CABA-201, a 4-1BB-containing ...
Posted by Michael Wonder on 26 Apr 2023
Atea Pharmaceuticals announces US FDA fast track designation granted to bemnifosbuvir, an investigational oral anti-viral, for the treatment of COVID-19
25 April 2023 - Atea Pharmaceuticals today announced that the United States FDA has granted fast track designation to bemnifosbuvir for ...
Posted by Michael Wonder on 24 Apr 2023
Avidity Biosciences granted FDA fast track designation for AOC 1044 for treatment of Duchenne muscular dystrophy mutations amenable to exon 44 skipping
24 April 2023 - Avidity Biosciences today announced that the US FDA has granted fast track designation to AOC 1044 for ...
Posted by Michael Wonder on 24 Apr 2023
Lantheus and POINT Biopharma announce FDA grants fast track designation for ¹⁷⁷Lu-PNT2002 for the treatment of metastatic castration resistant prostate cancer
24 April 2023 - Lantheus Holdings today announced the US FDA has granted fast track designation for 177Lu-PNT2002 for the treatment ...
Posted by Michael Wonder on 17 Apr 2023
Agenus receives fast track designation for botensilimab and balstilimab in colorectal cancer
17 April 2023 - Agenus has been granted fast track designation from the US FDA for the investigation of the combination ...
Posted by Michael Wonder on 17 Apr 2023
Candel Therapeutics receives FDA fast track designation for CAN-2409 in non-small-cell lung cancer
17 April 2023 - Fast track designation has the potential to facilitate the development and expedite the US FDA review of ...
Posted by Michael Wonder on 13 Apr 2023
SAB Biotherapeutics granted fast track designation from FDA for SAB-176 influenza immunotherapy with high cross-reactivity to multiple strains of influenza
13 April 2023 - FDA greenlights advancement of SAB-176 Phase 2b trial and manufacturing approach to address influenza strain change. ...
Posted by Michael Wonder on 12 Apr 2023
Kala Pharmaceuticals receives FDA fast track designation for KPI-012, a human MSC-S therapy for persistent corneal epithelial defect
12 April 2023 - Kala Pharmaceuticals today announced that the US FDA has granted fast track designation for Kala’s human mesenchymal ...
Posted by Michael Wonder on 11 Apr 2023
RegenxBio receives FDA fast track designation for RGX-202, a novel gene therapy candidate for the treatment of Duchenne muscular dystrophy
11 April 2023 - RGX-202 is a potential one-time AAV therapeutic for the treatment of Duchenne and includes an optimised transgene ...