FDA Approval The latest news regarding FDA applications, processes, and approval. This section contains releases regarding the Food and Drug Administration’s consideration of new products, drugs, therapies and treatments. Find announcements covering every stage of the FDA application process, from filing to eventual approval, including appeals, resubmissions, and safety alerts.

Latest

08:43 ET FDA approves new treatment for complicated urinary tract and complicated intra-abdominal infections

The U.S. Food and Drug Administration has approved Recarbrio (imipenem, cilastatin and relebactam), an antibacterial drug product to treat adults...


08:35 ET FDA Clears Erchonia's FX 635 for Relief of Chronic Musculoskeletal Pain

Erchonia Corporation, the global leader in the manufacturing and development of low level laser therapy technology ("3LT"), today announces that the...


08:00 ET DURECT Announces that the FDA Agreed to File the Full Response to the POSIMIR® Complete Response Letter as a Complete Class 2 Resubmission

DURECT Corporation (Nasdaq: DRRX) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged that the submission of DURECT's...


00:39 ET Q'Apel Medical Announces FDA Clearance for Walrus Balloon Guide Catheter

Q'Apel Medical announced today that it received U.S. Food and Drug Administration clearance for its novel walrus Balloon Guide Catheter (BGC). In the ...


Jul 16, 2019, 13:23 ET BTL Continues to Revolutionize Non-Invasive Aesthetics by Extending the Sculpting Power of EMSCULPT® to the Arms and Legs

BTL, the manufacturer behind the game-changing EMSCULPT technology, is continuing to raise the bar in aesthetics and non-invasive body shaping....


Jul 16, 2019, 06:00 ET Medical Coaches Awarded Contract by State of Colorado to Manufacture Mobile Opioid Clinics

Medical Coaches (www.medcoach.com), a leading manufacturer of mobile medical clinics, has been selected to produce six mobile health units,...


Jul 15, 2019, 12:46 ET Abbott Receives U.S. Approval of Next-Generation MitraClip®, Bringing New Enhancements to Abbott's Leading MitraClip Platform

Abbott (NYSE: ABT) today announced the company has received U.S. Food and Drug Administration (FDA) approval for the most advanced MitraClip™ heart...


Jul 15, 2019, 12:05 ET MSN Labs/Novadoz Pharmaceuticals Early Success Continues With FDA Approval Of Generic Abiraterone

MSN Labs, the parent company of Novadoz Pharmaceuticals, was granted FDA approval to market Abiraterone Acetate 250mg tablets, a generic version of...


Jul 15, 2019, 10:00 ET FDA approves Bayer's Gadavist® (gadobutrol) injection as the first and only contrast agent for use in cardiac MR in adult patients with known or suspected coronary artery disease

Bayer announced today the U.S. Food and Drug Administration (FDA) has approved Gadavist® (gadobutrol) injection for use in cardiac magnetic resonance ...


Jul 15, 2019, 08:57 ET Soom Launches Mobile App That Notifies Patients, Caregivers and Nurses of Medical Device Recalls

Soom, a pioneer in utilizing barcode and knowledge graph technologies to bridge information gaps between data sources and physical products, has...


Jul 11, 2019, 15:05 ET Food and Drug Administration (FDA) to Speak at National Industrial Hemp Council (NIHC) 2019 Hemp Business Summit

The NIHC is pleased to announce Lowell Schiller as a keynote speaker at the National Industrial Hemp Council's 2019 Business Summit. The meeting will ...


Jul 11, 2019, 09:00 ET Abbott Announces FDA Approval of the Alinity™ s System, the Latest Technology for Screening and Protecting the U.S. Blood and Plasma Supply

Abbott (NYSE: ABT) announced today U.S. Food and Drug Administration (FDA) approval for its new blood and plasma screening Alinity™ s System. This...


Jul 11, 2019, 08:16 ET INSIGHTEC erhält FDA-Zulassung und CE-Zeichen für Exablate Neuro mit dem MR-System SIGNA Premier von GE

GE Healthcare, ein führendes Unternehmen in den Bereichen Medizintechnik und diagnostische und therapeutische Bildgebung, und INSIGHTEC®, ein...


Jul 11, 2019, 08:14 ET INSIGHTEC reçoit l'approbation de la FDA et le marquage CE pour l'Exablate Neuro avec le système d'IRM SIGNA Premier de GE

GE Healthcare, leader dans la technologie médicale et l'imagerie diagnostique et thérapeutique, et INSIGHTEC®, innovateur mondial dans le domaine des ...


Jul 11, 2019, 04:16 ET RaySearch Receives FDA Clearance for RayStation 8B Including Machine Learning Functionalities

RaySearch has received 510(k) clearance from the FDA in the USA for version 8B of the treatment planning system RayStation®. RayStation 8B was...


Jul 11, 2019, 04:00 ET INSIGHTEC recibe la aprobación de la FDA y la marca CE para Exablate Neuro

GE Healthcare, un líder en tecnología médica e imagen terapéutica y de diagnóstico, e INSIGHTEC®, un innovador global en tecnología médica de cirugía ...


Jul 10, 2019, 13:35 ET New FDA-Cleared Microbicidal Liquid Kills Deadly, Drug-Resistant Candida Auris Superbug on Contact

Scientists have identified a new ally in the battle against the deadly outbreak of the superbug Candida auris, currently found in more than 20...


Jul 10, 2019, 09:00 ET INSIGHTEC Receives FDA Approval and CE Mark for Exablate Neuro With GE SIGNA Premier MR System

GE Healthcare, a leader in medical technology and diagnostic and therapeutic imaging, and INSIGHTEC®, a global medical technology innovator of...


Jul 10, 2019, 08:07 ET La Roche-Posay Changes The Face Of Acne With Latest FDA Approved Acne Ingredient And Premieres Artificial Intelligence-Based Skin Analysis

La Roche-Posay is committed to improving access to dermatological care for people with acne, which affects over 50 million Americans. La Roche-Posay...


Jul 10, 2019, 07:30 ET Moleculin Files for New Patents for Annamycin After Receiving FDA Approval of Fast Track Designation

Moleculin Biotech, Inc. (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug...


Jul 10, 2019, 06:00 ET FDA Approves Katerzia™, the First and Only Amlodipine Oral Suspension, 1 mg/mL, for Pediatric Patients 6 Years of Age and Older

Azurity Pharmaceuticals, a specialty pharmaceutical company that makes safe, high-quality treatments for patients requiring customized formulations...


Jul 09, 2019, 14:53 ET FDA Clears Koios DS™ Breast 2.0 to Assist Physicians with AI-Based Software

Koios Medical, the leader in ultrasound diagnosis decision support software, announces its second 510(k) clearance from the U.S. Food and Drug...


Jul 09, 2019, 14:00 ET icotec AG erhält FDA-Zulassung für die Vermarktung des VADER®one Pedikelschraubensystems

icotec AG, ein Schweizer Unternehmen, gab heute bekannt, dass das VADER®one Pedikelschraubensystem die 510(k)-Zulassung der US-amerikanischen Food...


Jul 09, 2019, 13:52 ET icotec AG recibe la autorización de la FDA para comercializar su sistema de tornillos pediculares VADER®one

icotec AG, una empresa suiza, ha anunciado hoy que el sistema de tornillos pediculares VADER®one ha recibido la autorización 510(k) de la...


Jul 09, 2019, 09:19 ET ConTIPI Medical Has Received FDA Approval for the Marketing of a Unique Product for the Treatment of Pelvic Organ Prolapse in Women

This week, ConTIPI Medical Ltd. received US Food and Drug Administration (FDA) approval to market its new product, the first of its kind, designed to ...