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

13:25 ET First System for Dynamic Intra-operative Measurement of Segmental and Global Spine Alignment Receives FDA Clearance

MiRus is pleased to announce FDA 510(k) clearance of the GALILEO™ Spine Alignment Monitoring System, a non-optical, wireless, real-time measurement...


10:44 ET FDA approves first generics of Lyrica

On July 19, the U.S. Food and Drug Administration approved multiple applications for first generics of Lyrica (pregabalin) for the management of...


09:45 ET Water Street's Partnership with Leading Medical Products Company Leads to FDA Approval of the First and Only Ready-to-Use Insulin for IV Infusion

Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry, announced today that its development...


00:37 ET InvaGen (a Cipla Subsidiary) Receives Final Approval for Generic Version of Pfizer's Lyrica® (Pregabalin Capsules, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg)

InvaGen Pharmaceuticals, Inc. ("InvaGen"), a wholly-owned subsidiary of the leading global pharmaceutical company Cipla Limited (BSE: 500087; NSE:...


Jul 21, 2019, 19:00 ET Ascentage Pharma to Initiate Phase Ib Study of HQP1351 in Tyrosine Kinase Inhibitors -resistant Chronic Myeloid Leukemia Patients in the US

Ascentage Pharma, a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, hepatitis B virus and...


Jul 19, 2019, 09:00 ET ID Genomics' CLoNeT E. coli Assay in Development to Combat Antibiotic Resistant Urinary Tract Infections

ID Genomics, SPC today announced the completion of its first Pre-Submission meeting with the Food and Drug Administration for the CLoNeT E. coli...


Jul 18, 2019, 07:00 ET CTI BioPharma Announces Outcome From End-of-Phase-2a Meeting With U.S. Food and Drug Administration (FDA) Regarding Pacritinib for Treatment of Myelofibrosis

CTI BioPharma Corp. (Nasdaq: CTIC) ("CTI" or "the Company") today announced the outcome of a Type B, End-of-Phase-2a meeting with the U.S. Food and...


Jul 17, 2019, 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...


Jul 17, 2019, 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...


Jul 17, 2019, 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...


Jul 17, 2019, 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...