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EnGeneIC granted FDA “Fast-Track” Designation for Novel Armed Nanocell Drug Conjugate (ANDC) Pancreatic Cancer Therapeutic
December 07, 2023 19:51 ET | EnGeneIC
EneneIC has been granted Fast Track designation for use of its novel Armed Nanocell Drug Conjugate (ANDC) in PDAC patients.
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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 | 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...
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Tenaya Therapeutics Receives FDA Fast Track Designation for TN-201
May 02, 2023 07:50 ET | 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...
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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 | 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...
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Synlogic Granted FDA Fast Track Designation for SYNB1353 for the Treatment of Homocystinuria (HCU)
August 23, 2022 07:00 ET | 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...
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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 | 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...
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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 | 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...
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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 | 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...
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Vacaville Establishes Fast Track Program for Biotechnology Projects
November 19, 2020 11:15 ET | 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...
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PMV Pharma Granted FDA Fast Track Designation of PC14586 for the Treatment of Advanced Cancer Patients that have Tumors with a p53 Y220C Mutation
October 13, 2020 08:00 ET | PMV Pharmaceuticals, Inc.
CRANBURY, N.J., Oct. 13, 2020 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc., (Nasdaq: PMVP) a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic...