In this edition of Quick Notes, we cover FDA nods for a new sterilization method for duodenoscopes, an updated device for sleep apnea, a smaller continuous glucose monitor and a…

The FDA has finalized advice for generic drug sponsors on seeking meetings with the agency to discuss the impact of a new or revised product-specific guidance (PSG) on their ANDA…

A cohort study recently published in JAMA Network Open has found that Eli Lilly’s blockbuster antidiabetic drug Zepbound (tirzepatide) is linked to lower risks of major complications compared to GLP-1…

The FDA has given marketing authorization for a novel device for at home syphilis testing using a single drop of blood. Source: Drug Industry Daily

During the second session of the 118th Congress, FDAnews will track important pending legislation, that has been acted on by Dec. 31, 2023, to keep you updated on laws and…

This edition of Quick Notes features approvals for Adaptimmune’s Tecelra, Purdue Pharma’s Zurnai, Servier Pharmaceuticals’ Voranigo and Aurobindo’s Estradiol. Source: Drug Industry Daily

Velocity Pharma’s lack of oversight of the quality of the eye drops its contract manufacturer — Kilitch Healthcare India Limited who received its own Warning Letter for the eye drops…

Cresilon has received FDA clearance for its plant-based hemostatic gel technology Traumagel to be used to stop and control life-threatening bleeding in a matter of seconds when applied to a…

This week, the FDA issued rules on new device classifications for SARS-CoV-2 detection devices, devices that detect select microbial agents and some intravenous catheter separation devices. The agency also announced…

Omega Tech Labs received an FDA Warning Letter for inadequate procedures to prevent microorganisms in its combination product and failure to meet water quality standards in manufacturing following a Jan.…