ImCheck Receives FDA Fast Track Designation for ICT01 in Combination with Azacitidine and Venetoclax in First-Line Acute Myeloid Leukemia for Patients Unfit for Induction Chemotherapy Treatment
September 18, 2024 05:00 ET
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ImCheck Therapeutics SAS
ImCheck Receives FDA Fast Track Designation for ICT01in Combination with Azacitidine and Venetoclaxin First-Line Acute Myeloid Leukemiafor Patients Unfit for Induction Chemotherapy Treatment ICT01,...
Caribou Biosciences Announces the FDA has Granted Fast Track Designations to CB-010 in Refractory SLE and to CB-012 in Relapsed or Refractory AML
September 03, 2024 08:00 ET
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Caribou Biosciences, Inc.
-- Fast Track designation is designed to expedite clinical development and regulatory review timelines -- -- Additional FDA designation for CB-010 following earlier RMAT and Fast Track...
AC Immune’s PI-2620 Tau-PET Diagnostic in Phase 3 Receives Fast Track Designation in Three Neurodegenerative Conditions
August 28, 2024 09:00 ET
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AC Immune SA
AC Immune’s PI-2620 Tau-PET Diagnostic in Phase 3 Receives Fast Track Designation in Three Neurodegenerative Conditions PI-2620 is in Phase 3 development in Alzheimer’s disease by AC Immune’s...
Insignis Therapeutics Receives FDA Fast Track Designation for IN-001 for Anaphylaxis Treatment
August 13, 2024 07:30 ET
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Insignis Therapeutics, Inc.
Insignis’ liquid epinephrine sublingual spray for anaphylaxis, stable and usable under both extreme heat and cold, gains FDA Fast Track designation.
Tiziana Life Sciences Granted FDA Fast Track Designation
July 24, 2024 07:00 ET
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Tiziana Life Sciences Ltd.
NEW YORK, July 24, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with...
FDA Accepts Tiziana Life Sciences Fast Track Designation Submission for Treatment of Multiple Sclerosis
June 11, 2024 08:00 ET
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Tiziana Life Sciences Ltd.
NEW YORK, June 11, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via...
Compass Therapeutics Receives FDA Fast Track Designation for the Investigation of CTX-009 in Combination with Paclitaxel for the Treatment of Patients with Metastatic or Locally Advanced Biliary Tract Tumors That Have Been Previously Treated
April 25, 2024 08:00 ET
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Compass Therapeutics
CTX-009, the Company’s bispecific DLL4/VEGF-A antibody, in combination with paclitaxel, has shown promising clinical responses in patients with advanced biliary tract cancer (BTC) in its Phase 2 study...
AdrenoMed Receives FDA Fast Track Designation for Enibarcimab for Treatment of Septic Shock
April 10, 2024 08:00 ET
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Adrenomed AG
With a mortality rate of 20-30% for sepsis and 30-50% for septic shock in developed countries, sepsis represents an enormous public health burden and is responsible for almost 20% of all deaths...
EnGeneIC granted FDA “Fast-Track” Designation for Novel Armed Nanocell Drug Conjugate (ANDC) Pancreatic Cancer Therapeutic
December 07, 2023 19:51 ET
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EnGeneIC
EneneIC has been granted Fast Track designation for use of its novel Armed Nanocell Drug Conjugate (ANDC) in PDAC patients.
AC Immune Receives FDA Fast Track Designation for Anti-Amyloid-beta Active Immunotherapy, ACI-24.060, to Treat Alzheimer’s Disease
June 27, 2023 07:00 ET
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AC Immune SA
AC Immune Receives FDA Fast Track Designation for Anti-Amyloid-beta Active Immunotherapy, ACI-24.060, to Treat Alzheimer’s Disease Ongoing Phase 1b/2 ABATE study enrolling well and expanding to sites...