Boehringer receives U.S. FDA Breakthrough Therapy designation and initiates two phase III trials in MASH for survodutide
October 08, 2024 02:35 ET
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Boehringer Ingelheim
The U.S. FDA Breakthrough Therapy designation is for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and moderate or advanced fibrosis, based on...
Achieve Life Sciences Announces FDA Grants Breakthrough Therapy Designation to Cytisinicline for the Treatment of E-Cigarette or Vaping Nicotine Dependence
July 31, 2024 08:00 ET
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Achieve Life Sciences
SEATTLE and VANCOUVER, British Columbia, July 31, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and...
FDA grants global Medical Device company Biomimetic Innovations ‘Breakthrough Device’ designation for OsStic® Synthetic Injectable Structural Bio-Adhesive Bone Void Filler
January 19, 2024 10:15 ET
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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
January 06, 2022 16:02 ET
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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
January 04, 2022 07:00 ET
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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
October 04, 2021 09:10 ET
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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
May 13, 2021 06:00 ET
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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
January 19, 2021 09:30 ET
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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
November 16, 2020 08:00 ET
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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
October 06, 2020 09:00 ET
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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...