FierceBiotech5d
FDA clears first automated endoscope cleaning system with Nanosonics' CORIS
In an agency first, the FDA has cleared a system designed to clean out the complex inner channels of flexible endoscopes—a notorious source of hospital-acquired infections. Nanosonics ...
Beam announces FDA clearance of BEAM-302 investigational new drug application
Beam Therapeutics (BEAM) announced that the FDA has cleared the investigational new drug application for BEAM-302 for the treatment of alpha-1 ...
Intelligent Bio Solutions’ FDA Clearance Process Remains on Track for 2025 U.S. Launch
On December 18, 2024, the Company announced the submission of its 510 (k) premarket notification to the U.S. Food and Drug Administration (FDA) for review and clearance of its Intelligent ...
pharmaphorum3d
FDA clears first treatment for Prader-Willi syndrome
Soleno Therapeutics' Vykat XR has become the first FDA-approved treatment for Prader ... Vykat XR (diazoxide choline) has been cleared to treat hyperphagia – an intense and incessant urge ...
Investing6d
FDA clears Tenon Medical’s Catamaran system expansion
LOS GATOS, CA - Tenon Medical, Inc. (NASDAQ:TNON), a micro-cap medical device company with a market capitalization of $3.14 million and impressive gross margins of 52%, has received FDA clearance ...
Roll Call3d
Targeting FDA user fees would leave agency gutted, experts say
Health and Human Services Secretary Robert F. Kennedy Jr. and his allies rallied around removing industry influence from the Food and Drug Administration as part of their quest to Make America ...
BioWorld5d
FDA clears Biomérieux’s Vitek Compact antimicrobial resistance system
Biomérieux SA recently received U.S. FDA 510(k) clearance for its Vitek Compact Pro, a system for microorganism identification and Antibiotic Susceptibility Testing. The company hopes that the system ...
Becker's ASC4d
FDA clears first automated endoscope cleaning system
Nanosonics has received FDA De Novo clearance for its new Coris system, a technology designed to improve the cleaning of flexible endoscopes and reduce infection risk, according to a March 20 news ...
Investing6d
FDA clears Verve’s gene editing drug for heart disease trial
The FDA’s IND clearance marks a significant milestone for Verve in its mission to advance gene editing therapies for cardiovascular diseases. While the company’s stock has faced challenges ...
Nasdaq5d
Intelligent Bio Solutions On Track For 2025 U.S. Launch Of FDA-Cleared Fingerprint Drug Test
(RTTNews) - Intelligent Bio Solutions (INBS),Tuesday announced that its FDA clearance process for the Intelligent Fingerprint Drug Screening System is progressing as planned, with the company on ...
NBC News5d
FDA approves first new antibiotic for UTIs in nearly 30 years
According to GSK, the last time the FDA cleared a new class of antibiotics for uncomplicated UTIs was in 1996, with the approval of fosfomycin. (Last year, the agency approved the drug Pivya for ...
Food Safety News2d
FDA continues to look for source of pathogen in Listeria outbreaks
As of March 27, the outbreak had sickened 30 people, up from 28 a week ago. The FDA has not reported the age range of the patients or where they live. There are likely at least 60 patients in the ...