BioSpace News Archive

Somryst is the first FDA-authorized prescription digital therapeutic (PDT) for patients with chronic insomnia and the first product submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed through FDA’s Software Precertification Pilot Program Somryst delivers digital Cognitive Behavioral Therapy for insomnia, including algorithm-driven sleep restriction and consolidation recommendations, and provides patients with treat

Dynavax to provide CpG 1018, the adjuvant contained in U.S. FDA-approved HEPLISAV-B vaccine, to support the rapid development of COVID-19 vaccines

The Deputy Prime Minister will join ministers and Government of Canada officials to provide an update on COVID-19.

Company to hold investor conference call today, March 26, 2020 at 8:30 am ET –

OVAL independent Data Safety Monitoring Committee (DSMC) reviewed un-blinded data and determined that the study has met the interim pre-specified criterion, of an absolute percentage advantage of 10% or higher in CA-125 response in the VB-111 treated arm compared to control. The DSMC recommends that the study proceed without modification. Overall CA-125 response rate in the first 60 randomized evaluable patients is 53%. Assuming a balanced randomization, the response rate in the treatment arm

Company Honored for Capabilities, Expertise, Reliability, Compatibility, and Service in the Contract Development and Manufacturing Industry Named 2020 CMO Leadership Award Champion in Categories of Expertise and Service TUSTIN, Calif., March 26, 2020 (GLOBE NEWSWIRE) -- Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturin

Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced the rescheduling of its advisory committee meeting (AdCom) by the U.S. Food and Drug Administration (FDA), provided an update on expected first quarter 2020 financial performance, and announced new initiatives intended to ensure business conti

The recently FDA-approved GENOSYL® inhaled nitric oxide may have pulmonary and antiviral benefits in treating pulmonary hypertension and acute infectious diseases associated with the novel coronavirus[1] GENOSYL® DS facilitates outpatient use of inhaled nitric oxide in the treatment of cardiopulmonary symptoms associated with COVID-19 [26-March-2020] ATLANTA ,

Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, today announced that it has joined The Leukemia & Lymphoma Society (LLS) in the groundbreaking, collaborative Beat AML Master Clinical Trial for newly diagnosed patients 60 years of ag

GoHealth Urgent Care, one of the country’s largest, fastest-growing and most technology-forward urgent care companies, has exponentially broadened its reach and care platform in order to better meet healthcare consumers’ new realities.