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Keep up with the regulator's latest rulings on novel drugs and expanded indications, as the second half of 2023 promises some major milestone FDA approvals.
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Study Details Immune Cells Vital to Success of Vaccines against Coronavirus
9/21/2023
A study has revealed new details about a key population of immune system cells critical to successful vaccination against the pandemic virus, SARS-CoV-2.
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Study Published in Nature Reveals Discovery of Unique Vertebral Stem Cells with Potential to Revolutionize Patient Care
9/21/2023
In a groundbreaking study published in Nature, a collaborative team of researchers from Hospital for Special Surgery (HSS) and Weill Cornell Medicine have discovered a new stem cell uniquely present in the spine.
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JURA Bio Announces Partnership With Replay Product Company Syena to Advance T Cell Receptor NK Therapies in Cancer
9/21/2023
Collaboration leverages JURA Bio’s T cell receptor (TCR) discovery platform to discover and develop innovative therapies by applying AI and machine learning.
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Save the Date: Profound Medical to Host Virtual Analyst & Investor Day on October 13
9/21/2023
Profound Medical Corp., a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, will host an Analyst & Investor Day event on Friday, October 13, 2023 from 1:00 p.m. to approximately 3:30 p.m. Eastern Time.
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Leading Experts Join 7th Annual Global Summit on Precision Diagnosis and Treatment of Prostate Cancer
9/21/2023
AdMeTech Foundation is hosting the 7th Annual Global Summit on Precision Diagnosis and Treatment of Prostate Cancer. This virtual event will take place on September 21-23, 2023.
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Veracyte Announces Novel Afirma-Based Findings that Advance Molecular Understanding of Thyroid Cancer to Be Presented at the 2023 ATA Annual Meeting
9/21/2023
Veracyte, Inc. (Nasdaq: VCYT) today announced that three posters showcasing new data from the company’s Afirma Genomic Sequencing Classifier (GSC) will be presented at the 2023 American Thyroid Association (ATA) Annual Meeting being held in Washington, DC from September 27 to October 1.
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After a sluggish start to the year, experts expect an uptick in IPO offerings moving into fall, although it’s unlikely 2023 will fully shrug off its slump.
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PROCEPT BioRobotics Announces New Corporate Headquarters in San Jose
9/20/2023
PROCEPT BioRobotics® Corporation, a surgical robotics company focused on developing transformative solutions in urology, proudly announces the grand opening of its state-of-the-art global corporate headquarters in San Jose, California.
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Pathways to Progress: How Orphan Drug Designation Sparks Biotech Transformation
9/20/2023
As part of that process, the agency can grant Orphan Drug Designation (ODD) to a drug or biological product being developed to prevent, diagnose or treat a rare disease or condition.
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RefleXion Acquires Global Rights to Radiopharmaceutical Molecule from 3B Pharmaceuticals to Treat High Unmet Need Cancers Including Brain, Pancreatic and Liver
9/20/2023
RefleXion Medical, Inc., a therapeutic oncology company and 3B Pharmaceuticals (3BP) GmbH, a biotechnology company developing targeted radiopharmaceutical drugs and diagnostics for cancer detection and treatment, announced an exclusive licensing agreement for RefleXion to develop and commercialize a specific 3BP molecule to direct its SCINTIX™ biology-guided radiotherapy.
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ORIC Pharmaceuticals to Participate in the 2023 Cantor Global Healthcare Conference
9/20/2023
ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced that management will participate in a fireside chat at the 2023 Cantor Global Healthcare Conference on Thursday, September 28, 2023, at 8:00 a.m. ET.
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scPharmaceuticals Announces Positive Feedback from Two FDA Meetings on Key Long-Term Growth Initiatives
9/19/2023
scPharmaceuticals Inc. today announced that the Company has received positive feedback from the U.S. Food and Drug Administration (FDA) on two key long-term growth initiatives.
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Marius Pharmaceuticals Expands Access of KYZATREX™ (testosterone undecanoate) to Department of Veterans Affairs (VA), Pledging Support for Proper Hormonal Balance Among Military Personnel
9/19/2023
Marius Pharmaceuticals is proud to announce the expansion of access to its FDA-approved oral testosterone therapy, KYZATREX™, to the Department of Veteran Affairs (VA).
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FDA Roundup: September 19, 2023
9/19/2023
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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Institute for Myeloma & Bone Cancer Research Announces Publication in Targeted Oncology
9/19/2023
The Institute for Myeloma & Bone Cancer Research (IMBCR) announces the publication in Targeted Oncology on the outstanding survival of 161 unselected, new patients with multiple myeloma (MM) who started treatment from 2006 to 2022 at Berenson Cancer Center.
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Profound Medical to Participate in the 2023 Cantor Global Healthcare Conference
9/19/2023
Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”) today announced that management will present an update on the Company’s business at the 2023 Cantor Global Healthcare Conference on Tuesday, September 26, 2023 at 4:55 p.m. Eastern Time in NYC.
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POINT Biopharma and Athebio Announce Partnership to Develop Designed Ankyrin Repeat Protein Targeted Radioligands
9/18/2023
POINT Biopharma Global Inc. and Athebio AG announced a collaboration and license agreement to develop and commercialize DARPin-targeted radioligands.
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Medigene AG Announces Lead Selection for MDG2011 Representing the First TCR-T Therapy of its KRAS Library
9/18/2023
Medigene AG (Medigene, the “Company”, FSE: MDG1, Prime Standard) announces today that it has selected its lead candidate for MDG2011, a T cell receptor engineered T cell (TCR-T) therapy targeting KRAS (Kirsten rat sarcoma viral oncogene homologue) G12V with HLA-A*11 and being developed in combination with the Company’s PD1-41BB costimulatory switch protein (CSP) technology.
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ESSA Pharma Announces Initiation of Phase 2 Study Evaluating Masofaniten (EPI-7386) in Combination with Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer
9/18/2023
ESSA Pharma Inc today announced the initiation of the Phase 2 portion of its Phase 1/2 study evaluating its lead candidate, masofaniten (formerly known as EPI-7386), a first-in-class N-terminal domain androgen receptor inhibitor, in combination with Astellas and Pfizer's antiandrogen enzalutamide in patients with metastatic castration-resistant prostate cancer ("mCRPC") naïve to second-generation antiandrogens.