SEATTLE, Sept. 6, 2019 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for the 14-Day version of the Carnation Ambulatory Monitor …
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Edesa Biotech Receives Approval from Health Canada for Clinical Study
TORONTO, ON / ACCESSWIRE / September 5, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has received approval from Health Canada to begin a clinical study of its investigational drug, EB02, which the company is developing as a potential …
Satsuma Pharmaceuticals Inc. Proposes Initial Public Offering of Common Stock
SOUTH SAN FRANCISCO, Calif., Sept. 3, 2019 /PRNewswire/ — Satsuma Pharmaceuticals, Inc. (“Satsuma”), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder) for the acute treatment of migraine, today announced that it has commenced an underwritten initial public offering of …
Edesa Biotech Reports Quarterly Financial Results
TORONTO, ON / ACCESSWIRE / August 14, 2019 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, today reported financial results for the three and six months ended June 30, 2019 and provided an update on its business. During the quarter, …
Bardy Diagnostics™ Selected As 1 of 6 Disruptive MedTech Startups for the HealthTech Arkansas Accelerator Program
SEATTLE, Aug. 9, 2019 /PRNewswire/ — Bardy Diagnostics, Inc., (“BardyDx”), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced that HealthTech Arkansas, a healthcare accelerator and investment fund that connects early-stage healthcare companies with disruptive technologies to Arkansas healthcare providers, has …
FDA Grants G1 Therapeutics Breakthrough Therapy Designation & Provides Q2 2019 Financial Update
Related Article: G1 Therapeutics Provides First Quarter 2019 Corporate and Financial Update RESEARCH TRIANGLE PARK, N.C., Aug. 07, 2019 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today provided a corporate and financial update for the second quarter ended June 30, 2019. …
Aurinia Releases Q2 2019 Financial Results
Related Article: Aurinia Reports First Quarter 2019 Financial Results & Recent Operational Highlights Review condensed consolidated financials here: https://ir.auriniapharma.com/press-releases/detail/153 VICTORIA, British Columbia–(BUSINESS WIRE)– Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused …
Zymeworks Releases Q2 2019 Financial Results
Related Article: Zymeworks Reports 2019 First Quarter Results VANCOUVER, British Columbia–(BUSINESS WIRE)– Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today reported financial results for the second quarter ended June 30, 2019. “We had a notable second …
Endotronix Receives conditional IDE approval from the US Food & Drug Administration
Related Article: Endotronix Receives 13485:2016 certification from the British Standards Institution (BSI) for its Quality Management System LISLE, Ill., Aug. 1, 2019 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced …
Edesa Biotech Completes Manufacturing for Upcoming Dermatitis Study
Related Article: Edesa Receives Approval to Proceed with U.S. Clinical Study TORONTO, ON / ACCESSWIRE / July 25, 2019 / Edesa Biotech, Inc. (NASDAQ: EDSA), a clinical-stage biopharmaceutical company, reported today that the company has completed the manufacturing of its lead …
Aurinia Strengthens Its Senior Management Team with the Appointment of Max Donley & Dr. Glenn Schulman
“It is a pleasure to welcome Max and Glenn to the team at this critical juncture for Aurinia. As we continue to build and expand the organization and prepare for the potential U.S. commercialization of voclosporin, their respective talents complement …
Celgene Exercises Commercial Option for Zymeworks’ Azymetric™ Platform Triggering $7.5MM Milestone Payment
VANCOUVER, British Columbia–(BUSINESS WIRE) — Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announced that its global biopharma partner Celgene Corporation has selected a lead therapeutic candidate in oncology for further development and exercised its option …
Endotronix Enrolls First Patient in SIRONA II CE Mark Trial
Study to support European clearance of Cordella™ Pulmonary Artery Sensor System for treatment of patients with chronic heart failure LISLE, IL – Endotronix Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced …
Opsens Releases Promising Q3 2019 Financials
QUEBEC CITY, July 11, 2019 /CNW Telbec/ – Opsens Inc. (“Opsens” or the “Company”) (TSX: OPS) (OTCQX: OPSSF) today reported its results for the third quarter of 2019. HIGHLIGHTS Consolidated revenues of $7.9 M for the third quarter of 2019 compared with $6.4 M for the third quarter of 2018, an increase …
Epilepsia Publishes Phase 2a Data for Staccato Alprazolam
– Staccato alprazolam is shown to rapidly suppress seizure activity at two minutes in five patients with epilepsy – – Staccato alprazolam generally well tolerated; no serious or severe adverse events reported – – Enrollment in Phase 2b, double-blind, placebo-controlled …