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 [...]
BD Receives FDA 510(k) Clearance for Potentially Transformative Fingertip Blood Collection Device
The BD MiniDraw Capillary Blood Collection System is less invasive than [...]
Brainomix Targets US Expansion with the Launch of its Cutting-Edge Stroke AI Platform Following Series of FDA Clearances
The recent FDA clearances included Brainomix 360 e-CTP and Brainomix [...]
Telesair Receives FDA Clearance for Bonhawa High Flow Oxygen Therapy System
“The best in class Bonhawa system greatly improves patient care [...]
FDA Grants Fast Track Designation to 9MW3011
9MW3011 has been approved to clinical study by NMPA and [...]
MicuRx receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation for Contezolid and Contezolid acefosamil
“We are pleased to gain the QIDP and Fast Track [...]
AusperBio Announces FDA Clearance of IND Application of AHB-137 in Chronic Hepatitis B Treatment
“The FDA’s clearance of our IND application to initiate clinical [...]
Janssen Submits Supplemental Biologics License Application to the U.S. Food and Drug Administration Seeking Approval of RYBREVANT® (amivantamab-vmjw) in Combination with Chemotherapy for the First-line Treatment of Patients with Locally Advanced or Metastatic EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer
“PAPILLON is the first randomized Phase 3 study in patients [...]