Month: September 2024

Life Molecular Imaging Receives FDA Fast Track Designation for [18F]PI-2620 in Tau PET Imaging Across Three Neurodegenerative Conditions

09/06/2024

Fast Track Designation Granted for use in patients being evaluated for Alzheimer’s Disease, Progressive Supranuclear Palsy, or Corticobasal Degeneration Excerpt from the Press Release: BOSTON, Aug. 28, 2024 /PRNewswire/ — Life Molecular Imaging (LMI) is pleased to announce that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to [18F]PI-2620 Injection, an investigational…

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Jupiter Endovascular Receives FDA Approval for U.S. Pivotal Study of Vertex Pulmonary Embolectomy System Using Endoportal Control

09/05/2024

Excerpt from the Press Release: MENLO PARK, Calif.–(BUSINESS WIRE)–Jupiter Endovascular, Inc., a medical technology startup developing a new class of endovascular procedures using Endoportal Control™ to bring the precision and control of direct surgical access to catheter-based interventions, announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption application…

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Apogee Therapeutics Announces First Participants Dosed in Phase 1 Clinical Trial of APG990, its Novel Half-Life Extended OX40L Antibody for the Treatment of Atopic Dermatitis and Other Inflammatory Diseases

09/04/2024

Interim safety and pharmacokinetic data from Phase 1 healthy volunteers trial anticipated in 2025 Initiation of the first clinical trial of APG777 and APG990 combination expected to commence in 2025 with the potential for greater efficacy in atopic dermatitis and across I&I diseases Excerpt from the Press Release: SAN FRANCISCO and WALTHAM, Mass., Aug. 19,…

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Sonnet BioTherapeutics Enters into Clinical Collaboration Agreement to Commence Investigator-Initiated and Funded Phase 1/2a Study of SON-1210 in Combination with Chemotherapy for the Treatment of Pancreatic Cancer

09/03/2024

Preclinical data has demonstrated the potential of SON-1210, the first albumin-binding bifunctional IL-12/IL-15 fusion protein, for solid tumor immunotherapy An Innovative Immuno Oncology Consortium (“IIOC”) led by Oncology experts funded by the Sarcoma Oncology Center will conduct an investigator-initiated Phase 1/2a study of SON-1210 in pancreatic cancer, an indication with significant unmet medical need Company…

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Evofem Biosciences Addresses the Impact of GLP-1 Medications on Oral Contraceptive Absorption and Introduces Phexxi as a Non-Oral Solution

09/02/2024

Excerpt from the Press Release: SAN DIEGO, Aug. 20, 2024 /PRNewswire/ — As the popularity of GLP-1 receptor agonists continues to surge in the treatment of obesity and type 2 diabetes, Evofem Biosciences, Inc. (OTCQB: EVFM) is raising awareness of the potential impact these medications may have on the effectiveness of oral contraceptives. With an…

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