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...
Tenaya Therapeutics Receives FDA Fast Track Designation for TN-201
May 02, 2023 07:50 ET
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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
December 09, 2022 06:45 ET
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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)
August 23, 2022 07:00 ET
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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...
7 Hills Pharma’s Clinical-stage Novel Immunostimulant 7HP349 Granted FDA Fast Track Designation for Anti-PD-1-resistant Metastatic Melanoma
March 08, 2022 17:32 ET
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7 Hills Pharma
HOUSTON, March 08, 2022 (GLOBE NEWSWIRE) -- 7 Hills Pharma LLC (“7 Hills” or “7HP”), a clinical-stage drug development company bringing to market a platform of unique, first-in-class oral small...
ARCA biopharma Announces First Patients Enrolled in ASPEN-COVID-19 Phase 2b Clinical Trial Evaluating rNAPc2 (AB201) as a Potential Treatment for COVID-19
December 15, 2020 08:30 ET
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ARCA biopharma, Inc.
rNAPc2 development focused on unmet need for treatments in hospitalized COVID-19 patients, including after availability of vaccinesrNAPc2 is the only novel compound being developed for COVID-19...
Aprea Therapeutics Receives FDA Fast Track Designation for Eprenetapopt in the Treatment of TP53 Mutant Acute Myeloid Leukemia (AML)
November 30, 2020 08:00 ET
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Aprea Therapeutics
BOSTON, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the...
Vacaville Establishes Fast Track Program for Biotechnology Projects
November 19, 2020 11:15 ET
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City of Vacaville
VACAVILLE, Calif., Nov. 19, 2020 (GLOBE NEWSWIRE) -- The City of Vacaville, which last month unveiled plans for the next generation of development of its world-class biomanufacturing cluster, has...