Tag: FDA approval
Pfizer-BioNTech’s Updated COVID-19 Vaccine Gets FDA Nod for 2026-2027
Pfizer Inc. and BioNTech SE said Thursday that U.S. regulators have cleared their refreshed COVID-19 shot, giving American providers a strain-matched option just as the fall...
First Autonomous Blood-Draw Robot Gets FDA Authorization
The U.S. Food and Drug Administration has given the green light to Aletta, a groundbreaking robotic system capable of performing blood draws entirely on its own...
FDA Approves Moderna’s mFLUSIVA, the First mRNA-Based Seasonal Influenza Vaccine
Moderna, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved mFLUSIVA (mRNA-1010), making it the first mRNA-based vaccine approved for seasonal influenza.
The vaccine...
Johnson & Johnson Secures FDA Approval for Dual-Energy Cardiac Ablation Catheter
Johnson & Johnson has secured U.S. regulatory clearance for its newest electrophysiology device, the Dual Energy THERMOCOOL SMARTTOUCH SF Platform. The system lets doctors...
FDA Approves Utebzi for Complicated Urinary Tract Infections
GSK plc and Spero Therapeutics announced that the US Food and Drug Administration (FDA) has approved Utebzi(tebipenem pivoxil). It is indicated for adult patients with complicated urinary tract...
FDA Grants Accelerated Approval to Sanofi’s Tzield® for Pediatric Stage 3 Type 1 Diabetes
The U.S. Food and Drug Administration has granted accelerated approval to Sanofi's Tzield® (teplizumab-mzwv) for children aged 8 to 17 years recently diagnosed with stage...
