FDA
Represents First Ever Epigenomic Controller, a New Class of Programmable mRNA Therapeutics, to Receive IND Clearance Phase 1/2 Clinical Trial Expected to Launch in 2H’22 and Will Evaluate the Safety and Preliminary Antitumor Activity of OTX-2002 Excerpt from the Press Release: CAMBRIDGE, Mass., July 14, 2022 /PRNewswire/ — Omega Therapeutics, Inc. (Nasdaq: OMGA) (“Omega”), today announced that it has received…
Read More
CAMBRIDGE, Mass.–(BUSINESS WIRE)–LG Chem recently announced the enrollment of first subject in Phase 1 clinical trial of LG203003, LG Chem’s second NASH (non-alcoholic steatohepatitis) drug in development. Excerpt from the Press Release: LG203003 received clearance from the U.S. Food and Drug Administration (FDA) in March 2022 for the Company’s Investigational New Drug (IND) application to…
Read More
FDA indicates the Company may proceed with the Phase 3 clinical study of buntanetap for the treatment of Parkinson’s disease Excerpt from the Press Release: BERWYN, Pa., July 7, 2022 /PRNewswire/ — Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company addressing neurodegenerative diseases, announced today that the Company…
Read More
– REACH is the first Phase 3 trial for this rare, progressive, and debilitating muscular disease –– Losmapimod is an oral small molecule that has the potential to be the first therapy to treat FSHD, the second most common form of muscular dystrophy –– U.S. Food and Drug Administration (FDA) granted Fast Track Designation in 2021 –…
Read More
Excerpt from the Press Release: HAMILTON, ON and BOSTON, June 23, 2022 /PRNewswire/ — Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) applications for [225Ac]-FPI-2059 (FPI-2059) and the…
Read More
Investigational New Drug Application Submitted by Omega Represents the First Epigenomic Controller in a New Class of Programmable mRNA Therapeutics Excerpt from the Press Release: CAMBRIDGE, Mass., June 15, 2022 /PRNewswire/ — Omega Therapeutics, Inc. (Nasdaq: OMGA) (“Omega”) today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug…
Read More
Excerpt from the Press Release: Now has orphan drug designation for SCLC and AML MADRID, Spain and CAMBRIDGE, Mass., June 08, 2022 (GLOBE NEWSWIRE) — Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that the U.S. Food and…
Read More
Automated and Easily Scalable Swab-Based Workflow Supports Increased Sample Throughput and Processing Consistency Excerpt from the Press Release: WALTHAM, Mass. & WATERTOWN, Mass.–(BUSINESS WIRE)–Rhinostics Inc. and Nexus Medical Labs recently received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a molecular SARS-CoV-2 test enabling unsupervised self-collection. The test, based on…
Read More
Dosing of the first subject in a Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety and efficacy of SP-103 (lidocaine topical system) 5.4% in subjects with moderate to severe acute lower back pain (LBP). The trial will enroll 80 patients with acute lower back pain. SP-103 is a pharmacologically validated…
Read More
Study to be Presented at the Global Embolization Oncology Symposium Technologies (GEST) 2022 Excerpt from the Press Release: LOS ALTOS, Calif.–(BUSINESS WIRE)–RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, today announces that it will present preclinical research supporting its planned second clinical indication, bile duct cancer,…
Read More