FDA grants global Medical Device company Biomimetic Innovations ‘Breakthrough Device’ designation for OsStic® Synthetic Injectable Structural Bio-Adhesive Bone Void Filler
19 janv. 2024 10h15 HE
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Biomimetic Innovations Ltd
FDA grants global Medical Device company Biomimetic Innovations ‘Breakthrough Device’ designation for OsStic® Synthetic Injectable Structural Bio-Adhesive.
Blue Note Therapeutics Receives Breakthrough Device Designation for Prescription-Only Digital Therapeutic for Acute Myeloid Leukemia
06 janv. 2022 16h02 HE
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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...
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
04 janv. 2022 07h00 HE
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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...
Zai Lab Partner Turning Point Therapeutics Granted Breakthrough Therapy Designation for Repotrectinib Treatment in Patients With NTRK-Positive, TKI-Pretreated Advanced Solid Tumors
04 oct. 2021 09h10 HE
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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...
CrannMed partners with leading Digital Research Organization, Meditrial to obtain “Breakthrough Device Designation” by the FDA for its innovative Knee Osteoarthritis Therapy
13 mai 2021 06h00 HE
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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...
Vivos Inc Receives Feedback from FDA on Breakthrough Designation Request
19 janv. 2021 09h30 HE
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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...
Kiniksa Announces Breakthrough Therapy Designation Granted to Vixarelimab for the Treatment of Pruritus Associated with Prurigo Nodularis
16 nov. 2020 08h00 HE
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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...
SetPoint Medical Receives FDA Breakthrough Device Designation for its Novel Bioelectronic Platform
06 oct. 2020 09h00 HE
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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...
Kiniksa Announces Breakthrough Therapy Designation for Rilonacept for the Treatment of Recurrent Pericarditis
20 nov. 2019 08h00 HE
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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...
Intercept Pharmaceuticals Announces 2014 Financial Results
02 mars 2015 06h00 HE
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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...