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Boehringer receives U.S. FDA Breakthrough Therapy designation and initiates two phase III trials in MASH for survodutide
08 oct. 2024 02h35 HE | 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...
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Achieve Life Sciences Announces FDA Grants Breakthrough Therapy Designation to Cytisinicline for the Treatment of E-Cigarette or Vaping Nicotine Dependence
31 juil. 2024 08h00 HE | 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...
Canine ex vivo tarsal arthrodesis: fixation by using a new bone tissue glue
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 | Biomimetic Innovations Ltd
FDA grants global Medical Device company Biomimetic Innovations ‘Breakthrough Device’ designation for OsStic® Synthetic Injectable Structural Bio-Adhesive.
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Blue Note Therapeutics Receives Breakthrough Device Designation for Prescription-Only Digital Therapeutic for Acute Myeloid Leukemia
06 janv. 2022 16h02 HE | 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
04 janv. 2022 07h00 HE | 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
04 oct. 2021 09h10 HE | 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
13 mai 2021 06h00 HE | 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
19 janv. 2021 09h30 HE | 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
16 nov. 2020 08h00 HE | 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
06 oct. 2020 09h00 HE | 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...