BioSpace News Archive

Bearpac Medical, LLC is pleased to announce that the FDA has granted 510(k) clearance for the Passio Pump Drainage System for the additional indication of home use to provide therapy for malignant and other recurrent pleural effusions.

Partnership Between Best-in-Class ACP Organizations Supports Person-Centered Care by Enabling Doctors and Nurses to Quickly Understand Patient Care Wishes

VolitionRx Limited, a multi-national epigenetics company developing simple, easy to use, cost effective blood tests to help diagnose a range of cancers and other diseases in both humans and animals, has announced the launch of its first product, the Nu.Q™ Vet Cancer Screening Test.

Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first-ever image-guided, catheter-based system for the diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the company has received an extension until May 19, 2021 to regain compliance with the Nasdaq minimum bid price requirement for continued listing.

OmniSeq®, an innovator in next generation sequencing (NGS) in oncology, today announced the company has received the International Organization for Standards (ISO) 13485:2016 certification for its Quality Management Systems (QMS)

Lore IO Inc., providers of an AI-powered common data model that enables faster vendor data onboarding and unified data views, today announced the immediate availability of Lore IO Life Sciences Cloud Analytics Packages,

OMNISOL® goes beyond simply disinfecting to provide long-lasting protection from dangerous pathogens during the pandemic, flu season and beyond

Rafael Pharmaceuticals, Inc. (“Rafael” or the “Company”), a leader in the growing field of cancer metabolism-based therapeutics, today announced it will initiate a Phase 2 clinical trial of CPI-613® (devimistat) in combination with hydroxychloroquine in patients with clear cell sarcoma of soft tissue. In partnership with Sara’s Cure and Sarcoma Alliance for Research through Collaboration (SARC),

Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced a planned response to a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA), regarding its New Drug Application (NDA) for Adamis’ ZIMHI ™ high dose naloxone injection product for the treatment of opioid overdose. The CRL, received November 13, 2020, identified deficiencies that the FDA determined must be corrected before the Agency can approve the NDA,

CRISPR Therapeutics (Nasdaq: CRSP) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the companies will host an investor webcast on December 9, 2020 at 8:00 a.m. ET to review clinical data presented during the Plenary Scientific Session at the annual ASH Meeting and Exposition from two ongoing Phase 1/2 clinical trials of the investigational CRISPR/Cas9 gene-editing therapy CTX001