FDA

FDA Grants Breakthrough Device Designation for Biological Dynamics’ Early-stage Pancreatic Cancer Detection Test

10/27/2021

Designation provides expedited regulatory review of Exo-PDAC, a liquid biopsy assay, built on the company’s Verita™ platform to detect pancreatic ductal adenocarcinoma earlier in high-risk adults Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Biological Dynamics, Inc., a multiomics liquid biopsy company focused on detecting cancers at the earliest stages, today announced that the U.S. Food…

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Moderna Announces FDA Authorization of a Booster Dose of Moderna’s COVID-19 Vaccine in the U.S.

10/25/2021

Emergency Use Authorization (EUA) granted for individuals 65 years of age and older, and individuals ages 18 through 64 within certain high-risk groups FDA also authorized the use of Moderna’s booster dose following primary vaccination with other authorized or approved COVID-19 vaccines Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering…

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“Pre-IPO” Biotech Startup Kills Advanced Stage Breast Cancers; Accepts Global Crowdfunding Investors

10/22/2021

Excerpt from the Press Release: SAN FRANCISCO, Oct. 14, 2021 /PRNewswire/ — In recognition of Breast Cancer Awareness Month, DeoBioSciences, Inc. (“DBS”), a minority/female founded, preclinical stage, biotech company, is highlighting its impressive research results against several types of treatment-resistant breast cancer. DeoBioSciences’ drug candidate, DBX-31, can selectively target and kill a wide range of tough, treatment-resistant, advanced…

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Agilent Receives FDA Companion Diagnostic Approval for Ki-67 IHC MIB-1 pharmDx in High-Risk Early Breast Cancer

10/20/2021

Excerpt from the Press Release: Agilent Technologies Inc. (NYSE: A) today announced its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is now FDA approved as an aid in identifying patients with early breast cancer (EBC) at high risk of disease recurrence, for whom adjuvant treatment with Verzenio® (abemaciclib) in combination with endocrine therapy is being considered. This…

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Viridian Therapeutics Submits Investigational New Drug Application for VRDN-001, an IGF-1R antibody for the treatment of Thyroid Eye Disease, to the U.S. Food and Drug Administration

10/18/2021

– VRDN-001 program remains on track for key proof of concept clinical data in Thyroid Eye Disease patients in the second quarter of 2022 – Excerpt from the Press Release: WALTHAM, Mass., Oct. 14, 2021 (GLOBE NEWSWIRE) — Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical company advancing new treatments for patients suffering from serious diseases…

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Phil Announces Partnership with Impel NeuroPharma in Support of Trudhesa™ (dihydroergotamine mesylate) Nasal Spray for the Acute Treatment of Migraine

10/06/2021

Excerpt from the Press Release: SAN FRANCISCO, Sept. 29, 2021 /PRNewswire/ — Phil, Inc. announces partnership with Impel NeuroPharma, Inc. (NASDAQ: IMPL) in support of Trudhesa™ (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) to provide technology-powered patient support and distribution services through Phil’s proprietary workflow to enhance the patient’s access to therapy. Trudhesa is indicated for the acute treatment of…

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TransCode Therapeutics Announces Publication in Cancer Nanotechnology of Preclinical Data Supporting Therapeutic Potential of TTX-MC138 in Metastatic Breast Cancer

09/30/2021

– Imaging study confirms the biodistribution of TTX-MC138 in models of metastatic cancer, supporting TransCode’s TTX platform for delivery of RNA targeted therapy to metastatic solid tumors – — eIND submission for TTX-MC138 anticipated in 1Q 2022 to support Phase 0 study in metastatic solid tumors, designed to establish proof of concept for TTX delivery platform — BOSTON–(BUSINESS…

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CARISMA Therapeutics Announces U.S. Food and Drug Administration Grants Fast Track Designation to CT-0508 for the Treatment of Patients with Solid Tumors

09/29/2021

PHILADELPHIA, Sept. 22, 2021 /PRNewswire/ — CARISMA Therapeutics Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, announced today that that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CT-0508, a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M) for the treatment of patients…

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SHEPHERD Therapeutics Presents First Public Data at 2021 ESMO Congress Highlighting Ability of DELVE Computational Approach to Optimize Therapeutic Selection for Cancer Patients

09/24/2021

Excerpt from the Press Release: BOSTON, Sept. 16, 2021 (GLOBE NEWSWIRE) — SHEPHERD Therapeutics, a company dedicated to catalyzing lifesaving treatments for cancer patients, is pleased to present an e-poster of results from a computational approach to optimizing therapeutic selection for cancer patients using the Company’s proprietary precision-oncology DELVE platform, at the European Society for…

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Intellia Therapeutics Announces U.S. FDA Acceptance of Investigational New Drug Application for NTLA-5001, its CRISPR/Cas9-Engineered TCR-T Cell Candidate for Acute Myeloid Leukemia

09/23/2021

Excerpt from the Press Release: NTLA-5001 is Intellia’s first ex vivo candidate using its proprietary cell engineering process for the treatment of cancer to enter clinical study NTLA-5001 targets Wilms’ Tumor 1 (WT1), an overexpressed intracellular antigen on many hematologic malignancies and solid tumors Initiation of patient screening in Phase 1/2a study of NTLA-5001 expected…

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