BioSpace News Archive

FDA

Radiopharm Theranostics Receives FDA Orphan Drug Designation for Trivehexin (RAD 301) in Pancreatic Cancer

Radiopharm Theranostics is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Ga68-Trivehexin (RAD 301) radiopharmaceutical technology for imaging of patients with pancreatic ductal adenocarcinoma (PDAC).

May 9, 2023
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3 min read
Business

Zevra Therapeutics to Report First Quarter 2023 Results on May 15, 2023

Zevra Therapeutics, Inc. has announced that it will host a conference call and live audio webcast on Monday, May 15, 2023, at 4:30 p.m. ET, to review its corporate and financial results for the first quarter of 2023.

May 9, 2023
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4 min read
BioForest

Adaptive Biotechnologies Announces FDA Acceptance of Genentech’s Investigational New Drug Application for the First Neoantigen-Directed T-Cell Therapy Product in Oncology

Adaptive Biotechnologies Corporation today announced that the U.S. Food and Drug Administration has accepted an investigational new drug (IND) application submitted by its collaborator, Genentech, a member of the Roche Group, for a T-cell receptor (TCR) based T-Cell Therapy.

May 9, 2023
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4 min read
Business

Sensei Biotherapeutics Reports First Quarter 2023 Financial Results and Recent Business Highlights

Sensei Biotherapeutics today reported financial results for the first quarter ended March 31, 2023, and provided recent business updates.

May 9, 2023
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8 min read
Vivos Therapeutics Announces Additional Strategic Initiatives Aimed at Accelerating Anticipated Timeline for Cash Flow Positive Operations

Vivos Therapeutics, Inc. today announced it has implemented a broad set of initiatives aimed at improving operational efficiencies, reducing expenses, and positioning Vivos to take advantage of current growth opportunities.

May 9, 2023
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5 min read
Fusion Pharmaceuticals to Present at the Guggenheim Healthcare Talks Radiopharmaceuticals Day

Fusion Pharmaceuticals Inc. today announced that the Company will participate in a fireside chat presentation at the Guggenheim Healthcare Talks Radiopharmaceuticals Day on Monday, May 15, 2023.

May 9, 2023
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2 min read
Business

Vaxxinity Reports First Quarter 2023 Financial Results and Provides Corporate Update

Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today reported financial results for the first quarter ended March 31, 2023 and provided a corporate update.

May 9, 2023
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9 min read
Genetown

Ratio Therapeutics Announces Opening of New Research and Development Facility

Ratio Therapeutics Inc. is pleased to announce the opening of its new 19,000-square-foot headquarters and R&D facility in the famous Innovation and Design Building located in Boston’s Seaport District.

May 9, 2023
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3 min read
Drug Development

Theranexus and BBDF Win FDA Approval on Efficacy Endpoints for the Phase III Trial to Evaluate Batten-1 in CLN3 Batten Disease

Theranexus and the Beyond Batten Disease Foundation, have announced receipt of approval from the Food and Drug Administration for the design and primary and secondary endpoints of the pivotal Phase III trial for Batten disease CLN3, at a meeting with the Division of Rare Diseases and Medical Genetics held in mid-April.

May 9, 2023
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8 min read
Business

Devyser Diagnostics AB publishes quarterly report for the period January to March 2023

The first quarter of the year saw continued strong growth, record gross margin and the launching of our first IVDR-approved product.

May 9, 2023
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3 min read