Pfizer and BioNTech Receive U.S. FDA Approval & Authorization for Omicron KP.2-adapted COVID-19 Vaccine
August 22, 2024 14:15 ET
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BioNTech SE
The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals 6 months of age and olderThe KP.2 adaptation is based on FDA...
Liquidia Files Litigation to Challenge Regulatory Exclusivity Blocking Access to YUTREPIA™ (treprostinil) inhalation powder for Patients Suffering with PAH and PH-ILD
August 22, 2024 06:00 ET
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Liquidia Corporation
Liquidia has filed litigation that challenges the recent decision by the FDA to grant 3-year new clinical investigation exclusivity to Tyvaso DPI.
U.S. FDA Grants Tentative Approval of YUTREPIA™ (treprostinil) Inhalation Powder for Patients with Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
August 19, 2024 06:00 ET
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Liquidia Corporation
The FDA has granted tentative approval of YUTREPIA™ (treprostinil) inhalation powder to treat adults with PAH and PH-ILD.
60 Degrees Pharma Provides University of Kentucky with Right of Reference to ARAKODA® NDA in Support of SJ733 Phase IIb Study
August 12, 2024 09:12 ET
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Sixty Degrees Pharmaceuticals
60 Degrees Pharma grants U of Kentucky a right of reference to ARAKODA® NDA for a Phase IIb trial combining SJ733 with tafenoquine to treat vivax malaria.
PsyCan Comments on FDA Decision Re: Lykos MDMA-Assisted Therapy Application
August 09, 2024 18:28 ET
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Psychedelics Canada
Psycan comments on USFDA's recent decision to request a third phase 3 trial prior to approval of
PharmAla Comments on USFDA Decision regarding MDMA-Assisted Therapy and Announces Patent Granting for ALA-002
August 09, 2024 18:18 ET
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PharmAla Biotech
PharmAla expresses disappointment in USFDA's decision to request a third Phase 3 for MDMA and announces the patent granting for a safer MDMA analog variant
Kronos Advanced Technologies Announces Unrestricted Status for DogeSPAC LLC Units
August 08, 2024 14:22 ET
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Kronos Advanced Technologies Inc.
Los Angeles, CA , Aug. 08, 2024 (GLOBE NEWSWIRE) -- Los Angeles, August 8, 2024 — Kronos Advanced Technologies, Inc. (OTC: KNOS) is pleased to announce that the interests in DogeSPAC LLC, a...
Axogen, Inc. Announces New Leadership Appointments
August 08, 2024 07:05 ET
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Axogen, Inc.
The Board of Directors appoints Michael Dale as new CEO and Director, effective August 9, 2024Dale replaces Karen Zaderej, who will remain in an advisory role for nine monthsCurrent Member of the...
George Medicines files New Drug Application with FDA for novel low dose triple combination for treatment of hypertension following successful international Phase III development program
August 06, 2024 07:00 ET
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George Medicines
George Medicines files New Drug Application with FDA for novel low dose triple combination for treatment of hypertension following successful international Phase III development program ...
Kronos Advanced Technologies Inc. and Yasheng Group Announce Strategic Collaboration to Develop Revolutionary Nuclear Battery.
August 05, 2024 06:18 ET
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Kronos Advanced Technologies Inc.
Los Angeles, CA , Aug. 05, 2024 (GLOBE NEWSWIRE) -- August 5th, 2024 – Kronos Advanced Technologies Inc. (OTC: KNOS) and Yasheng Group (OTC: HERB) are excited to announce a strategic collaboration...