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
18 sept. 2024 05h00 HE
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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
03 sept. 2024 08h00 HE
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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
28 août 2024 09h00 HE
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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
13 août 2024 07h30 HE
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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
24 juil. 2024 07h00 HE
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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
11 juin 2024 08h00 HE
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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
25 avr. 2024 08h00 HE
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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
10 avr. 2024 08h00 HE
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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
07 déc. 2023 19h51 HE
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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
27 juin 2023 07h00 HE
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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...