FDA

Iterative Scopes Receives FDA Clearance for AI-Assisted Polyp Detection Device SKOUT™

09/29/2022

SKOUT’s advanced computer vision capabilities enable physicians to detect pre-cancerous lesions in the colon with more accuracy Excerpt from the Press Release: CAMBRIDGE, Mass. & MINNEAPOLIS–(BUSINESS WIRE)–Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, and Provation, the premier software and SaaS provider of clinical productivity and workflow automation solutions, announced today that SKOUT™…

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TRACON Pharmaceuticals Announces Submission of IND Application for CTLA-4 Antibody YH001 for the Treatment of Front-line Sarcoma Patients in Combination with Envafolimab

09/29/2022

Excerpt from the Press Release: SAN DIEGO, Aug. 08, 2022 (GLOBE NEWSWIRE) — TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, today announced that the company submitted an Investigational…

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Marengo Therapeutics Advances First-In-Class Selective T cell Activator, STAR0602, into Human Trials in Solid Tumors and Enters Cooperative Research and Development Agreement with the National Cancer Institute

09/22/2022

Excerpt from the Press Release: CAMBRIDGE, Mass., Sept. 16, 2022 /PRNewswire/ — Marengo Therapeutics, a company pioneering novel therapeutics targeting the T cell receptor Vβ chain (TCR Vβ) to selectively activate the right T cell subsets to fight cancer, today announced it is advancing its lead TCR activator, STAR0602, into the clinic following clearance of its…

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Larimar Therapeutics Announces FDA Clearance to Initiate the 25 mg Cohort of a Phase 2 Dose Exploration Trial of CTI-1601 in Friedreich’s Ataxia Patients

09/20/2022

Initiation of the Phase 2 trial is expected in Q4 2022, with top-line data expected in 2H 2023 Company management hosting webcast and conference call today at 8:30 a.m. ET Excerpt from the Press Release: BALA CYNWYD, Pa., Sept. 14, 2022 (GLOBE NEWSWIRE) — Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused…

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Atea to Advance Global Phase 3 Registrational Study of Bemnifosbuvir in High-Risk Non-Hospitalized Patients with COVID-19

09/16/2022

Novel Phase 3 Trial Design to Evaluate Bemnifosbuvir as Monotherapy and Combination Antiviral Therapy for COVID-19 Trial to Focus on High-Risk Patients at Greatest Risk for Disease Progression Trial Expected to Initiate in Fourth Quarter 2022 Conference Call at 8:30 a.m. ET Today Excerpt from the Press Release: BOSTON, Sept. 13, 2022 (GLOBE NEWSWIRE) —…

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Vaxcyte Completes Enrollment of Phase 2 Study Evaluating Safety, Tolerability and Immunogenicity of VAX-24 in Adults 65 Years and Older

09/13/2022

— Company Expects to Announce Topline Data from Study in Adults 65 Years and Older in the First Half of 2023 — — Vaxcyte Remains on Track to Announce Topline Data from the Phase 1 and Phase 2 Portions of the VAX-24 Proof-of-Concept Study in Adults Aged 18-64 in October or November 2022 — —…

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2seventy bio Announces Plans to Initiate KarMMa-9 Study of Abecma (idecabtagene vicleucel) in Newly Diagnosed Multiple Myeloma Patients

09/12/2022

This study will evaluate Abecma in patients with suboptimal response to transplant Data from KarMMa-3 and KarMMa-2 studies of Abecma will be presented at future medical meeting Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–2seventy bio, Inc. (Nasdaq: TSVT) today announced plans to initiate the KarMMa-9 study to evaluate Abecma (idecabtagene vicleucel) in newly diagnosed…

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Moderna Completes Application To U.S. Food And Drug Administration For Emergency Use Authorization Of Omicron-Targeting Bivalent Covid-19 Booster Vaccine, mRNA-1273.222

09/02/2022

mRNA-1273.222 Targets BA.4/BA.5 Strains of Omicron Variant Pending Authorization, Moderna Ready to Ship Bivalent Booster mRNA-1273.222 in September Clinical Data Available for Moderna’s Bivalent COVID-19 Booster Vaccines Have Met All Primary Endpoints and Support Request for Emergency Use Authorization Excerpt from the Press Release: CAMBRIDGE, MA / ACCESSWIRE / August 23, 2022 / Moderna, Inc.…

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Inhibikase Therapeutics Announces FDA Clearance of Investigational New Drug Application for IkT-001Pro for the Treatment of Chronic Myelogenous Leukemia

08/30/2022

Excerpt from the Press Release: BOSTON and ATLANTA, Aug. 26, 2022 /PRNewswire/ — Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease, Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced that the U.S. Food and Drug Administration (FDA)…

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Cure Rare Disease Receives FDA Approval to Administer First-in-Human CRISPR Therapeutic

08/22/2022

The first-of-its-kind, CRISPR-based therapeutic aims to stop the progression of Duchenne muscular dystrophy in a single-patient dosing Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Cure Rare Disease (CRD) – a Boston-based 501c3 nonprofit biotech – announces the approval from the U.S. Food and Drug Administration (FDA) to administer its very first therapeutic. The drug, named CRD-TMH-001, treats…

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