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...
Tenaya Therapeutics Receives FDA Fast Track Designation for TN-201
02 mai 2023 07h50 HE
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Tenaya Therapeutics, Inc.
TN-201 Being Developed for the Potential Treatment of MYBPC3-associated HCM Dosing in Phase 1 Clinical Trial Expected to Commence in Q3 2023 SOUTH SAN FRANCISCO, Calif., May 02, 2023 (GLOBE...
Pfizer and BioNTech Receive U.S. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza
09 déc. 2022 06h45 HE
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BioNTech SE
NEW YORK and MAINZ, GERMANY, DECEMBER 9, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the companies have received Fast Track Designation from the U.S. Food and Drug...
Synlogic Granted FDA Fast Track Designation for SYNB1353 for the Treatment of Homocystinuria (HCU)
23 août 2022 07h00 HE
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Synlogic, Inc.
CAMBRIDGE, Mass., Aug. 23, 2022 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its...