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

01:00 ET Roche announces the first FDA-approved CMV test for use in hematopoietic stem cell transplant recipients

 Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the United States Food and Drug Administration (FDA) approval of the first cytomegalovirus...


May 24, 2016, 09:00 ET FDA Approves Medic Vision SafeCT®-29 that Helps Achieve Radiation Safety

 Medic Vision Imaging Solutions, Ltd., the leading innovator of vendor-independent solutions for low-dose CT exams, announced today the FDA...


May 24, 2016, 08:30 ET Cynosure Receives FDA Clearance to Market New PicoSure® Energy Delivery System for Tattoos and Pigmented Lesions

 Broadening its product platform for tattoo removal and skin revitalization, Cynosure, Inc. (NASDAQ: CYNO) today announced that it has...


May 24, 2016, 08:08 ET Eisai to Present Analyses at 2016 ASCO Annual Meeting from Trials Supporting Recent FDA Approvals for the Company's Oncology Therapies

Eisai Inc. announced today presentations of new analyses of studies supporting U.S. Food and Drug Administration (FDA) approvals at the 2016...


May 24, 2016, 07:31 ET Allergan Announces FDA Acceptance of NDA Filing for Oxymetazoline HCI Cream 1.0%

Allergan plc (NYSE: AGN) today announced that the New Drug Application (NDA) filing for oxymetazoline HCl cream 1.0%, an investigational topical...


May 24, 2016, 06:00 ET Interventional Spine, Inc. announces FDA Clearance of Lordotic Opticage™

 Interventional Spine, Inc. announced today FDA clearance of its 80 Lumbar Lordotic Opticage™ Expandable Intervertebral Body Fusion...


May 24, 2016, 04:55 ET L'utilisation d'un dispositif non chirurgical pour la circoncision masculine a été approuvée par l'Organisation mondiale de la santé pour les adolescents

PrePex - le SEUL dispositif non chirurgical de circoncision masculine - a été conçu spécialement pour renforcer les...


May 23, 2016, 20:50 ET Seqirus receives FDA approval for FLUCELVAX QUADRIVALENT™ (Influenza Vaccine) for people four years of age and older

 Seqirus announced today that the US Food and Drug Administration (FDA) has approved FLUCELVAX QUADRIVALENT™ (Influenza Vaccine), the...


May 23, 2016, 12:47 ET EndoChoice® Announces FDA Clearance of its Orca™ Sterile, Single-Use Air/Water and Suction Valves

 EndoChoice Holdings, Inc. (NYSE: GI) announced it received 510(k) clearance for its new Orca™ sterile, single-use air/water and...


May 23, 2016, 08:00 ET Non-Surgical Male Circumcision Device Approved for Use in Adolescents by the World Health Organization

The World Health Organization (WHO) expanded the Intended Use of the currently-prequalified PrePex device to include adolescents aged 13 years,...


May 23, 2016, 07:30 ET Mylan Launches First Generic Doryx® Delayed-Release Tablets, 200 mg

 Mylan N.V. (Nasdaq: MYL, TASE: MYL) today announced the U.S. launch of Doxycycline Hyclate Delayed-Release (DR) Tablets USP, 200 mg, a generic...


May 19, 2016, 08:30 ET Boston Scientific Receives U.S. FDA Approval for Precision Montage™ MRI Spinal Cord Stimulator System

 Boston Scientific Corporation (NYSE: BSX) today announced the launch of the Precision Montage™ MRI Spinal Cord Stimulator (SCS) System...


May 19, 2016, 07:00 ET Celator Pharmaceuticals® Announces VYXEOS™ Granted Breakthrough Therapy Designation

 Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) today announced that the United States Food and Drug Administration (FDA) granted Breakthrough...


May 18, 2016, 15:00 ET Roche receives FDA Approval for novel PD-L1 biomarker assay

 Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced approval of the VENTANA PD-L1 (SP142) Assay1 by the US Food and Drug Administration (FDA)...


May 18, 2016, 13:58 ET FDA approves new, targeted treatment for bladder cancer

The U.S. Food and Drug Administration today approved Tecentriq (atezolizumab) to treat the most common type of bladder cancer, called urothelial...


May 18, 2016, 13:18 ET Petition Asks FDA to Remove All Unapproved Fluoride Supplements from Market

 The U.S. Food & Drug Administration (FDA) has issued a "Warning Letter" that orders a manufacturer of fluoride drops and tablets to...


May 18, 2016, 09:08 ET FDA Grants IND Approval to Stemedica for a Traumatic Brain Injury Phase IIa Clinical Trial

 Stemedica Cell Technologies, Inc. (Stemedica) received an FDA investigational new drug (IND) approval for a United States-based, Phase IIa...


May 18, 2016, 08:35 ET Industry-Leading Physicians to Conduct Free Seminars on Relieving Uterine Fibroid Pain

 In partnership with the Fibroid Education Center, Dr. Suzanne LeBlang, an industry leader treating uterine fibroids, and Dr. Stern, an...


May 17, 2016, 17:46 ET Aratana Therapeutics Granted FDA Approval of ENTYCE® (capromorelin oral solution)

 Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on the licensing, development and commercialization of...


May 17, 2016, 17:32 ET At-Home Medical Device for Treatment of Stretch Marks Now Available

Strialite®, the first-of-its kind medical device cleared by the Food and Drug Administration (FDA) for the at-home treatment of stretch marks,...


May 17, 2016, 11:25 ET Millennium Dental Technologies Receives First-of-Its Kind FDA Clearance for Tissue Regeneration

With periodontal disease evident in eighty-five percent of adults in the United States, Millennium Dental Technologies (MDT) is pleased to announce...


May 17, 2016, 11:03 ET Mission Pharmacal Receives FDA Approval for Liquid Potassium Iodide Oral Solution for Nuclear Emergency Management

Mission Pharmacal Company today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New...


May 17, 2016, 11:00 ET VM BioPharma Announces FDA Fast Track Designation Granted for Investigational Gene Therapy VM202 for Patients with Amyotrophic Lateral Sclerosis (ALS)

 VM BioPharma, the United States division of ViroMed Co., Ltd. in Seoul, South Korea (KOSDAQ:084990), today announced that the U.S. Food and...


May 16, 2016, 15:56 ET PLI Publishes FDA Deskbook: A Compliance And Enforcement Guide

 Practising Law Institute (PLI) announces the release of their newest publication, FDA Deskbook: A Compliance and Enforcement Guide. Written...


May 16, 2016, 14:30 ET Polymedco Announces the Launch of Epi proColon® in the United States

 Polymedco is proud to announce the launch of Epi proColon®, a newly FDA approved blood test for colorectal cancer screening in patients...


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