Theratechnologies soumet un supplément d'approbation préalable à la FDA pour l’environnement de la fabrication d’EGRIFTA SV(MD)
18. Dezember 2024 13:30 ET
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Theratechnologies
MONTRÉAL, 18 déc. 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (« Theratechnologies » ou la « Société ») (TSX : TH) (NASDAQ : THTX), une société biopharmaceutique axée sur la mise au...
Theratechnologies Announces Filing of FDA Prior Approval Supplement for EGRIFTA SV® Manufacturing Environment
18. Dezember 2024 13:30 ET
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Theratechnologies
MONTREAL, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and...
Sobi Announces FDA Acceptance of New Drug Application for Avatrombopag (DOPTELET®) for the Treatment of Pediatric Immune Thrombocytopenia
12. Dezember 2024 06:59 ET
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Sobi, Inc.
WALTHAM, Mass., Dec. 12, 2024 (GLOBE NEWSWIRE) -- Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced that the U.S. Food and Drug Administration...
FemPulse Receives FDA IDE Approval for the Pivotal Clinical Trial of its Wearable Bioelectronic Device for Overactive Bladder in Women
11. Dezember 2024 15:18 ET
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FemPulse
SAN FRANCISO, Dec. 11, 2024 (GLOBE NEWSWIRE) -- FemPulse™ announced today Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin its EVANESCE II...
NeurAxis Inc. Announces FDA 510(k) Clearance of RED for Testing and Evaluation of Patients with Chronic Constipation
10. Dezember 2024 09:00 ET
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NeurAxis, Inc.
RED has been designed to duplicate test performance of traditional balloon expulsion test (BET) and manual sensation testing devices without needing electronics or software. NeurAxis Inc. will begin...
uniQure Announces Alignment with FDA on Key Elements of Accelerated Approval Pathway for AMT-130 in Huntington’s Disease
10. Dezember 2024 07:05 ET
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uniQure Inc.
~ U.S. Food and Drug Administration (FDA) agrees that data from ongoing Phase I/II studies compared to a natural history external control may serve as the primary basis for a Biologics License...
CytoSorbents Announces Rights Offering
09. Dezember 2024 07:00 ET
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CytoSorbents
CytoSorbents Announces Rights Offering Exclusive to Stockholders Who Hold or Have Bought CTSO Common Stock by Market Close on Friday, December 13, 2024
NurExone Announces Promising Preclinical Results in Restoring Vision After Optic Nerve Damage
06. Dezember 2024 16:03 ET
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NurExone Biologic Inc
NurExone announces significant findings from a preclinical study of the potential of its portfolio drug, ExoPTEN, for repairing Optic Nerve Damage (OND)
KRTL Holding Announces KRTL Biotech Facilitates FDA Registration of SIGMACORP as a U.S. Pharmaceutical Manufacturer
05. Dezember 2024 09:00 ET
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KRTL Holding Group
Lakewood, CO, Dec. 05, 2024 (GLOBE NEWSWIRE) -- KRTL Holding Group, Inc. (OTC: KRTL) announces that its subsidiary, KRTL Biotech Inc., has successfully registered Industria Químico Farmaceutica...
Kronos Advanced Technologies Announces Cyber Monday Savings of Up to 50% on Innovative Air Purification Products, Plus Exclusive Deals Throughout the Holiday Season
02. Dezember 2024 06:18 ET
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Kronos Advanced Technologies Inc.
Los Angeles, CA, Dec. 02, 2024 (GLOBE NEWSWIRE) -- Los Angeles, CA- December 2, 2024 /GlobeNewsWire/ KRONOS ADVANCED TECHNOLOGIES, INC. (OTC MARKETS: KNOS) ("KNOS" or the "Company"), an...