InflaRx Receives FDA Fast Track Designation for Treatment of Ulcerative Pyoderma Gangrenosum
July 06, 2022 07:30 ET
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InflaRx N.V.
US Food and Drug Administration awards Fast Track designation for the treatment of ulcerative pyoderma gangrenosumFast track follows recently reported orphan drug designation by both US FDA and EMA ...
HOOKIPA Announces First Patient Enrolled in Phase 2 Trial Evaluating HB-200 and Pembrolizumab for Treatment of Head and Neck Cancer and Reports FDA’s Fast Track Designation
January 18, 2022 07:00 ET
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HOOKIPA Pharma Inc.
First patient dosed with HB-200 and pembrolizumab combination for treatment of 1st-line advanced/metastatic head and neck cancer in Phase 2 arm of ongoing Phase 1/2 trial Fast Track Designation...
Celsion Corporation Receives FDA Fast Track Designation for GEN-1 in Advanced Ovarian Cancer
February 22, 2021 07:30 ET
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Celsion CORP
Celsion’s Commitment to Promoting Immune System Solutions to Fight Life-Threatening Diseases Granted an Accelerated Development Pathway Designation Provides Potential for an Expedited...
UPDATE - Rafael Pharmaceuticals Receives FDA Fast Track Designation for CPI-613® (devimistat) for the Treatment of Acute Myeloid Leukemia (AML)
December 15, 2020 11:09 ET
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Rafael Pharmaceuticals, Inc.
CRANBURY, N.J., Dec. 15, 2020 (GLOBE NEWSWIRE) -- Rafael Pharmaceuticals, Inc. (“Rafael” or the “Company”), a leader in the growing field of cancer metabolism-based therapeutics, announced today...
Rafael Pharmaceuticals Receives FDA Fast Track Designation for CPI-613® (devimistat) for the Treatment of Acute Myeloid Leukemia (AML)
December 15, 2020 09:00 ET
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Rafael Pharmaceuticals, Inc.
CRANBURY, N.J., Dec. 15, 2020 (GLOBE NEWSWIRE) -- Rafael Pharmaceuticals, Inc. (“Rafael” or the “Company”), a leader in the growing field of cancer metabolism-based therapeutics, announced today...
Rhizen Pharmaceuticals S.A. and Curon Biopharmaceutical Limited Announce an Exclusive Licensing Agreement to Develop and Commercialize Tenalisib, a Dual PI3K Delta and Gamma Inhibitor for Oncology in Greater China
October 12, 2020 08:00 ET
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Rhizen Pharmaceuticals SA
La Chaux-de-Fonds, Switzerland and Shanghai, China. October 12, 2020, Oct. 12, 2020 (GLOBE NEWSWIRE) -- Rhizen Pharmaceuticals S. A. (Rhizen), a Switzerland-based privately held clinical-stage...
Geron Receives Positive Opinion from the EMA Committee for Orphan Medicinal Products for Orphan Drug Designation in the European Union for Imetelstat to Treat Myelodysplastic Syndromes
July 01, 2020 08:30 ET
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Geron Corporation
Designation would provide 10-year period of marketing exclusivity in the European Union after product approvalPatients are currently enrolling in a Geron-sponsored Phase 3 clinical trial in lower risk...
Geron Announces Two Poster Presentations at Upcoming American Society of Hematology Annual Meeting
November 06, 2019 09:18 ET
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Geron Corporation
MENLO PARK, Calif., Nov. 06, 2019 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq: GERN) today announced that two abstracts related to imetelstat, the Company’s first-in-class telomerase inhibitor,...
Geron Announces First Patient Dosed in IMerge Phase 3 Clinical Trial in Lower Risk Myelodysplastic Syndromes
October 10, 2019 17:30 ET
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Geron Corporation
MENLO PARK, Calif., Oct. 10, 2019 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq: GERN) today announced that the first patient has been dosed in the IMerge Phase 3 clinical trial to evaluate...
Geron Announces Fast Track Designation Granted to Imetelstat for Relapsed/Refractory Myelofibrosis
September 30, 2019 16:19 ET
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Geron Corporation
MENLO PARK, Calif., Sept. 30, 2019 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq: GERN) today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation...