Nyxoah Submits Fourth and Final Module in PMA Application for Genio to the US FDA
Genio is a different approach to hypoglossal nerve stimulation (HGNS). [...]
FDA Approves PYZCHIVA ® (ustekinumab-ttwe), Samsung Bioepis’ Biosimilar to Stelara
“The FDA approval of PYZCHIVA as a biosimilar to Stelara [...]
Neuromod Partners with 14 New US Tinnitus Clinics to Expand Availability of FDA Approved Lenire
Lenire has become the most in-demand tinnitus treatment device in [...]
Aurion Biotech Receives Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy Designation for Its Drug Candidate AURN001
Sterling Chung, Vice President of Regulatory Affairs and Quality at [...]
Justice Department and FDA Announce Federal Multi-Agency Task Force to Curb the Distribution and Sale of Illegal E-Cigarettes
“Unauthorized e-cigarettes and vaping products continue to jeopardize the health [...]
Tris Pharma Receives U.S. FDA Approval for Once-Daily ONYDA XR (clonidine hydrochloride) Extended-Release Oral Suspension, the First-and-Only Liquid Non-Stimulant ADHD Medication
ONYDA XR is indicated for the treatment of ADHD as [...]
FDA Grants AI-Powered Notal Vision Home OCT “SCANLY” De Novo Marketing Authorization
“We are very excited to receive FDA authorization to market [...]
Inspira™ Announces 95% Accuracy Results for HYLA ™ Blood Sensor, Planning FDA Submission for Clearance in 2024
The development of the first HYLA variant, key to this [...]
CymaBay Submits New Drug Application to FDA for Seladelpar for the Treatment of Primary Biliary Cholangitis
Seladelpar has been granted Breakthrough Therapy Designation by the FDA [...]
Ad Astra Diagnostics Receives 510(k) Clearance of QScout™ Hematology Analyzer
QScout is the first hematology platform designed for simple, fast [...]