NurExone Demonstrates Extended Therapeutic Window of ExoPTEN Post Spinal-Cord Injury in Preclinical Study
September 06, 2024 16:03 ET
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NurExone Biologic Inc
NurExone demonstrates a longer timeframe of ExoPTEN treatment can be effectively administered post Spinal-Cord Injury
Politicized Medicine Hindered Use of Ivermectin for COVID, according to the Journal of American Physicians and Surgeons
September 04, 2024 11:12 ET
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Association of American Physicians and Surgeons
The politicized response to Covid included a war on the use of ivermectin. Studies have conflicting results. The issue is at a stalemate.
Longeveron® Announces Positive Type C Meeting with U.S. FDA Regarding Pathway to BLA for Lomecel-B™ in Hypoplastic Left Heart Syndrome (HLHS)
September 03, 2024 09:00 ET
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Longeveron
Longeveron announces positive Type C meeting with FDA, clarifying regulatory pathway to BLA submission for Lomecel-B for hypoplastic left heart syndrome.
Caribou Biosciences Announces the FDA has Granted Fast Track Designations to CB-010 in Refractory SLE and to CB-012 in Relapsed or Refractory AML
September 03, 2024 08:00 ET
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Caribou Biosciences, Inc.
-- Fast Track designation is designed to expedite clinical development and regulatory review timelines -- -- Additional FDA designation for CB-010 following earlier RMAT and Fast Track...
Ipsen's Iqirvo Shows Strong Start in Primary Biliary Cholangitis, Now Faces Rivalry from Gilead's Livdelzi
August 29, 2024 14:14 ET
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Spherix Global Insights
EXTON, PA, Aug. 29, 2024 (GLOBE NEWSWIRE) -- The past few months have ushered in a new era of treatment for patients suffering from primary biliary cholangitis (PBC), marked by the approval of...
Kronos Advanced Technologies Announces Letter of Intent to Acquire Leading Data-Marketing and Direct to Consumer marketing Company, Suarez Corporation Industries, for Total Potential Consideration of $25 Million
August 27, 2024 06:18 ET
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Kronos Advanced Technologies Inc.
PArkersburg, West Virginia, Aug. 27, 2024 (GLOBE NEWSWIRE) -- Parkersburg, WV - August 27, 2024 - Kronos Advanced Technologies Inc. (OTC: KNOS), a leader in advanced air purification and innovative...
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.