BioSpace News Archive

– Sotatercept received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) in PAH in 2019 – – In the spring of 2020, sotatercept received Breakthrough Therapy designation from the FDA and Priority Medicines (PRIME) designation from the European Medicines Agency (EMA), both in PAH –

Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that the company conducted a Type B Meeting for omidubicel with the U.S. Food and Drug Administration (FDA) on Friday, December 11, 2020.

Commercial Launch of Ergonomix2 Planned for 2021 Approval Accelerates Path to Europe for Motiva Mia Pre-Commercial European Mia Procedures to Begin in Second Half of 2021 SANTA BARBARA, Calif., Dec. 14, 2020 (GLOBE NEWSWIRE) -- Establishment Labs Holdings Inc. (NASDAQ: ESTA), a medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, today announced it has received a CE mark for its next generation Motiva Ergonomix2 ® silicon

Aditx Therapeutics, Inc. (Aditxt) (the “Company”) (Nasdaq: ADTX), and Todos Medical Ltd. (OTCQB: TOMDF), today announced the signing of a distribution agreement for AditxtScore™ for COVID-19, with planned availability in January 2021.

Reflect Scientific, Inc. (Symbol: RSCF), a provider of diverse products and services for the biotechnology, pharmaceutical, and transportation industries, announced that an additional patent has been granted by United States Patent Office for an ultra-low temperature (-160C) chest freezer based on the proven Cryometrix liquid nitrogen cooling technology. Ultra-low temperature mechanical freezers face unique issues. Lack of temperature uniformity

Legend Biotech Corporation (NASDAQ: LEGN) (“Legend Biotech”), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to evaluate LB1901, the company’s investigational autologous chimeric antigen receptor T-cell (CAR-T) therapy,

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca today announced the initiation of TROPION-Lung05, a global phase 2 trial of datopotamab deruxtecan (Dato-DXd; DS-1062), a TROP2 directed antibody drug conjugate (ADC), in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with actionable genomic alterations previously treated with kinase inhibitor therapy and platinum-based chemotherapy with or without immunotherapy.

Aytu BioScience, Inc. (NASDAQ:AYTU) , a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, today announced that management will present at the LD Micro Virtual Investor Conference on Tuesday, December 15 at 2:20pm ET.

Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced plans to expand its vonoprazan development program into non-erosive reflux disease (NERD). NERD is a major subcategory of gastroesophageal reflux disease (GERD) and is characterized by reflux-related symptoms in the absence of esophageal mucosa

The current public health crisis has changed nearly every facet of our lives, but perhaps no shift has been more profound than how we have adapted to work, when required to be around others.