Blue Note Therapeutics Receives Breakthrough Device Designation for Prescription-Only Digital Therapeutic for Acute Myeloid Leukemia
January 06, 2022 16:02 ET | Blue Note Therapeutics
SAN FRANCISCO, Jan. 06, 2022 (GLOBE NEWSWIRE) -- Blue Note Therapeutics, a prescription digital therapeutics company dedicated to easing the burden of cancer and improving outcomes, today announced...
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FDA Grants Breakthrough Therapy Designation for Cullinan Oncology’s CLN-081 in Patients with Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
January 04, 2022 07:00 ET | Cullinan Oncology, Inc.
CAMBRIDGE, Mass., Jan. 04, 2022 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM) (“Cullinan”), a biopharmaceutical company focused on developing a diversified pipeline of targeted...
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Zai Lab Partner Turning Point Therapeutics Granted Breakthrough Therapy Designation for Repotrectinib Treatment in Patients With NTRK-Positive, TKI-Pretreated Advanced Solid Tumors
October 04, 2021 09:10 ET | Zai Lab Limited
SHANGHAI, China and SAN FRANCISCO, Oct. 04, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) partner Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company...
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CrannMed partners with leading Digital Research Organization, Meditrial to obtain “Breakthrough Device Designation” by the FDA for its innovative Knee Osteoarthritis Therapy
May 13, 2021 06:00 ET | Meditrial
NEW YORK, May 13, 2021 (GLOBE NEWSWIRE) -- Meditrial Inc, a leading Global Digitally Driven Research Organization, is pleased to announce its successful collaboration with CrannMed Limited in...
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Vivos Inc Receives Feedback from FDA on Breakthrough Designation Request
January 19, 2021 09:30 ET | Vivos Inc.
Richland WA, Jan. 19, 2021 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Although we were unable to secure a Breakthrough Device Designation from the FDA, this was a well-designed process that...
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Kiniksa Announces Breakthrough Therapy Designation Granted to Vixarelimab for the Treatment of Pruritus Associated with Prurigo Nodularis
November 16, 2020 08:00 ET | Kiniksa Pharmaceuticals, Ltd.
HAMILTON, Bermuda, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company with a pipeline of assets designed to modulate...
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SetPoint Medical Receives FDA Breakthrough Device Designation for its Novel Bioelectronic Platform
October 06, 2020 09:00 ET | SetPoint Medical
VALENCIA, Calif., Oct. 06, 2020 (GLOBE NEWSWIRE) -- SetPoint Medical, Inc. today announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for...
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Kiniksa Announces Breakthrough Therapy Designation for Rilonacept for the Treatment of Recurrent Pericarditis
November 20, 2019 08:00 ET | Kiniksa Pharmaceuticals, Ltd.
HAMILTON, Bermuda, Nov. 20, 2019 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company focused on discovering, acquiring, developing and...
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Intercept Pharmaceuticals Announces 2014 Financial Results
March 02, 2015 06:00 ET | Intercept Pharmaceuticals, Inc.
NEW YORK, March 2, 2015 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), a clinical stage biopharmaceutical company focused on the development and commercialization of...