BioSpace News Archive

Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for its Phase 2 clinical trial of pemvidutide for obesity.

Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, announced today that it will present findings from its drug discovery and development programs at the 45th Annual MidWinter Meeting of the Association for Research in Otolaryngology (ARO).

Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company advancing new treatments for patients suffering from serious diseases underserved by current therapies, today announced the United States Food and Drug Administration (FDA) clearance of its investigational new drug (IND) application of VRDN-002.

Athira Pharma, Inc., a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and stop neurodegeneration, announced the appointment of Grant Pickering to its Board of Directors.

OraSure Technologies, Inc. (NASDAQ: OSUR), announced today that its InteliSwab® COVID-19 rapid tests have been authorized by the U.S. Food and Drug Administration (FDA) for use in children ages 2 to 14. InteliSwab® was previously authorized for use in adults and in children 15 to 17 when administered by an adult.

Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), today announced positive topline clinical data from the placebo-controlled, double-blind portion of its Phase 3 MAESTRO-NAFLD-1 (non-alcoholic fatty liver disease) safety study of resmetirom.

XORTX Therapeutics Inc. is pleased to take this opportunity to provide an update on the Company’s progress in 2021 and provide insights on 2022 goals.

Celltrion Healthcare Canada Limited is very pleased to announce that Health Canada granted a notice of compliance (NOC) on December 24, 2021 for Yuflyma™, a high-concentration (100mg/mL), low-volume, citrate-free, and latex-free biosimilar to Humira® (adalimumab).

Leica Biosystems, a cancer diagnostics company, has entered into an agreement with Leap Therapeutics (NASDAQ: LPTX), a biotechnology company, to develop a companion diagnostic to detect Dickkopf-related protein 1 (DKK1).

Quest Diagnostics announced that they will now offer consumer-initiated laboratory testing powered by QuestDirect™ in collaboration with Walmart.