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Ensoma Unveils Three Programs Leveraging In Vivo Hematopoietic Stem Cell Engineering Platform to Target Genetic, Immune and Oncological Diseases
Rgenta Therapeutics Announces First Patients Dosed in Phase 1a/b Clinical Trial of RGT-61159, an Oral Small Molecule Targeting MYB, in Adenoid Cystic Carcinoma (ACC) and Colorectal Cancer (CRC)
FDA clears surgical hydrogel nerve cap for preventing phantom limb pain in amputees
Tulavi Therapeutics has received a de novo clearance from the FDA for a surgical kit designed to help reduce long-term phantom limb pains among people who have had an amputation. The Allay nerve cap system includes an absorbable hydrogel that encases the end of a severed nerve, preventing it from… Read More
Rgenta Therapeutics Announces FDA Clearance of IND Application for RGT-61159, an Oral Small Molecule RNA Modulator Designed to Halt Disease-Driver MYB Production in Adenoid Cystic Carcinoma (ACC) and Colorectal Cancer (CRC)
First-in-human Phase 1a/1b clinical trial will evaluate orally available, RGT-61159 designed to selectively target MYB RNA and inhibit oncogenic MYB protein production Preclinical data supporting the clinical trial were recently presented at the American Society of Clinical Oncology Annual Meeting (ASCO 2024) WOBURN, Mass., July 10, 2024 /PRNewswire/ — Rgenta Therapeutics, a biotechnology… Read More
Phanes Therapeutics’ PT217 granted Fast Track Designation by the FDA
SAN DIEGO, April 8, 2024 /PRNewswire/ — Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PT217 for the treatment of patients with extensive-stage small cell lung cancer… Read More
Sirius Therapeutics Announces Dosing of First Subject in Chinese Phase 1 Clinical Trial of FXI siRNA Anticoagulant
SAN DIEGO, CA & SHANGHAI, April 1st, 2024 – Sirius Therapeutics today announced it has dosed the first subject in a Chinese Phase 1 trial of SRSD107, its next generation siRNA therapeutic targeting coagulation Factor XI (FXI), for the prevention and treatment of thromboembolic disorders. This study is to evaluate… Read More
Allecra Therapeutics Announces U.S. FDA Approval for EXBLIFEP® for the Treatment of Complicated Urinary Tract Infections
–Company Receives Five-year Exclusivity Extension Through GAIN Act — SAINT-LOUIS, France & WEILL AM RHEIN, Germany, February 27,2024 – Allecra Therapeutics (“Allecra”), a biopharmaceutical company developing novel therapies to combat antibiotic resistance, announced today that the U.S. Food and Drug Administration (FDA) has approved EXBLIFEP® (cefepime/enmetazobactam), as a treatment for… Read More
Eccogene Announces US IND Approval for GLP-1 Receptor Agonist ECC5004
Boston/Shanghai/November 3rd, 2022 — Eccogene announced that the U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application to commence a Phase I trial of its glucagon-like peptide 1 receptor agonist (GLP-1 RA) ECC5004 for type 2 diabetes mellitus (T2DM). This study will evaluate the safety,… Read More
Clover’s COVID-19 Booster Vaccine Candidate Demonstrates Robust Neutralization of Dominant Omicron BA.5
— 12 to 61-fold increase in neutralizing antibodies against BA.5 among participants receiving SCB-2019 (CpG 1018/Alum) as a homologous third dose or with a history of prior SARS-CoV-2 infection — — BA.5 neutralizing antibody levels were approximately two to four-fold higher than BA.1 neutralizing antibody levels, demonstrating a potentially differentiated… Read More