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RSS FeedPosted by Michael Wonder on 10 Jun 2026
Matisse Pharmaceuticals receives FDA fast track designation for isupartob sodium in sepsis
9 June 2026 - Matisse Pharmaceuticals today announced that the US FDA has granted fast track designation for its lead compound ...
Posted by Michael Wonder on 10 Jun 2026
Imugene's azer-cel granted FDA fast track designation for CLL/SLL and MZL
9 June 2026 - Imugene is pleased to announce that the US FDA has granted fast track designation to azer-cel ...
Posted by Michael Wonder on 04 Jun 2026
Verastem Oncology announces US FDA fast track designation for VS-7375, an oral and potential best in class investigational KRAS G12D (ON/OFF) inhibitor for the treatment of KRAS G12D mutated locally advanced or metastatic non-small cell lung cancer
3 June 2026 - Verastem Oncology today announced that the US FDA has granted hast track designation to VS-7375, an oral ...
Posted by Michael Wonder on 03 Jun 2026
Terremoto Biosciences granted FDA fast track designation for TER-2013, an AKT1 selective small molecule inhibitor for breast cancer
3 June 2026 - Terremoto Biosciences today announced that the US FDA granted fast track designation for TER-2013, the Company’s lead ...
Posted by Michael Wonder on 03 Jun 2026
TearSolutions receives FDA orphan drug and fast track designations for Lacripep in neurotrophic keratitis
2 June 2026 - TearSolutions today announced receiving FDA orphan drug and fast track designations for Lacripep in neurotrophic keratitis. ...
Posted by Michael Wonder on 02 Jun 2026
FDA grants fast track designation to Merakris’ MTX-001
2 June 2026 - Merakris Therapeutics today announced that the US FDA has granted fast track designation to MTX-001, the Company’s ...
Posted by Michael Wonder on 01 Jun 2026
Nouscom receives US FDA fast track designation for NOUS-209, a novel immunotherapy for the prevention of Lynch syndrome-associated cancers
1 June 2026 - Nouscom today announced that the US FDA has granted fast track designation to NOUS-209 for the prevention ...
Posted by Michael Wonder on 28 May 2026
Solu Therapeutics granted FDA fast track designation for STX-0712 for treatment of chronic myelomonocytic leukaemia
27 May 2026 - Solu Therapeutics today announced that the US FDA has granted fast track designation to STX-0712, the company's ...
Posted by Michael Wonder on 27 May 2026
Autobahn Therapeutics announces US FDA fast track designation for elunetirom, a CNS directed thyroid hormone receptor agonist, for the adjunctive treatment of bipolar depression
26 May 2026 - Autobahn Therapeutics today announced that the US FDA granted fast track designation to elunetirom, the Company’s lead ...
Posted by Michael Wonder on 15 May 2026
Alloplex Biotherapeutics receives FDA fast track designation for Suplexa in colorectal cancer indication
13 May 2026 - Alloplex Biotherapeutics announces that the US FDA has granted fast track designation to Suplexa for the treatment ...
Posted by Michael Wonder on 15 May 2026
INmune Bio receives FDA fast track designation for XPro1595 in early Alzheimer's disease
14 May 2025 - INmune Bio today announced that the US FDA has granted fast track designation to XPro (pegipanermin), the ...
Posted by Michael Wonder on 12 May 2026
Coya Therapeutics has been granted US FDA fast track designation for COYA 302 for the treatment of amyotrophic lateral sclerosis
12 May 2026 - Coya Therapeutics today announced that the US FDA has granted fast track designation for COYA 302, ...
Posted by Michael Wonder on 12 May 2026
Sironax’s SARM1 inhibitor SIR2501 granted FDA fast track designation in chemotherapy-induced peripheral neuropathy
11 May 2026 - Sironax today announced that the US FDA has designated its SARM1 inhibitor SIR2501 as a fast track ...
Posted by Michael Wonder on 11 May 2026
Zai Lab receives US FDA fast track designation for zocilurtatug pelitecan (Zoci), a DLL3 targeting ADC, for treatment of extrapulmonary neuroendocrine carcinomas
11 May 2026 - Zai Lab today announced the US FDA has granted fast track designation to zocilurtatug pelitecan (zoci, formerly ...
Posted by Michael Wonder on 07 May 2026
Repertoire Immune Medicines announces FDA fast track designation for its investigational immune medicine, RPTR-1-201
7 May 2026 - Repertoire Immune Medicines today announced that the US FDA has granted fast track designation to RPTR-1-201 for ...