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

Jan 10, 2018, 04:08 ET BioProtect lance une étude clinique multicentrique internationale suite à l'exemption pour dispositif expérimental (IDE) de la FDA

La FDA a accordé une approbation d'exemption pour dispositif expérimental (IDE - Investigational Device Exemption approval) pour mener une étude...


Jan 10, 2018, 04:07 ET BioProtect Launches an International Multi-Center Clinical Study Following FDA investigational Device Exemption (IDE)

FDA has granted investigational Device Exemption approval (IDE) to conduct a pivotal clinical study examining the use of the ProSpace[TM]...


Jan 09, 2018, 09:00 ET BioProtect Launches an International Multi-Center Clinical Study Following FDA Investigational Device Exemption (IDE)

BioProtect, the technology leader in biodegradable balloon spacers protecting normal tissue during radiation therapy, announced the launch of its...


Jan 09, 2018, 07:00 ET Cepheid Receives FDA Clearance and CLIA Waiver for Xpert® Xpress Flu Test

Cepheid announced today it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments...


Jan 09, 2018, 03:00 ET Xcision Receives FDA 510(k) Clearance for the GammaPod Stereotactic Radiotherapy System for Breast Cancer

Xcision Medical Systems, LLC has announced that the GammaPod Stereotactic Radiotherapy System, the world's first noninvasive external beam system...


Jan 08, 2018, 09:00 ET Clearbridge BioMedics' ClearCell® FX1 system achieves U.S. FDA listing

Clearbridge BioMedics today announced that it has successfully registered its target cell enrichment device, the ClearCell® FX1 system, with the...


Jan 08, 2018, 08:10 ET Varian Halcyon Treatment System Receives Taiwan FDA Approval

Varian (NYSE: VAR) today announced its Halcyon™ system has received Taiwan FDA approval, which allows the company to market this new cancer...


Jan 08, 2018, 08:00 ET Nevro Receives FDA Approval for Senza II™ Spinal Cord Stimulation System Delivering HF10™ Therapy

Nevro Corp. (NYSE:NVRO), a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain,...


Jan 08, 2018, 08:00 ET STS Medical Receives FDA Regulatory Clearance

STS Medical Ltd. ("S.T.Stent"), a portfolio company of The Trendlines Group Ltd. ("Trendlines") (SGX: 42T; OTCQX: TRNLY), announced today that it...


Jan 08, 2018, 08:00 ET AbbVie's Upadacitinib Granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for Atopic Dermatitis

AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA)...


Jan 05, 2018, 09:00 ET Spruce Biosciences Receives EMA Orphan Drug Designation for SPR001 for the Treatment of Congenital Adrenal Hyperplasia

Spruce Biosciences, a clinical-stage biotechnology company developing novel therapies for rare endocrine disorders, today announced that the...


Jan 05, 2018, 09:00 ET FDA Approves XGEVA® (denosumab) For The Prevention Of Skeletal-Related Events In Patients With Multiple Myeloma

Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application...


Jan 04, 2018, 11:01 ET Cerebrotech Visor™ Receives FDA Clearance

Cerebrotech Medical Systems, an innovative medical device company developing neurotechnology solutions, has received clearance from the Food and...


Jan 04, 2018, 10:45 ET Sight Sciences Expands Surgical Portfolio with FDA Clearance of the OMNI™ Surgical System

Sight Sciences, Inc., a venture-backed, commercial stage ophthalmic device company, today announced U.S. Food and Drug Administration (FDA) 510(k)...


Jan 04, 2018, 07:15 ET Novartis drug Promacta® receives FDA Breakthrough Therapy designation for first-line use in severe aplastic anemia (SAA)

Novartis today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Promacta® (eltrombopag) for...


Jan 03, 2018, 16:30 ET Zimmer Biomet Announces FDA Clearance of the Sidus® Stem-Free Shoulder System

Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced it has received U.S. Food and Drug...


Jan 03, 2018, 10:03 ET Cantex Pharmaceuticals, Inc. Announces FDA Orphan Drug Designation Has Been Granted to CX-01 for Treatment of Acute Myeloid Leukemia

Cantex Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing proprietary pharmaceuticals that improve the treatment of...


Jan 03, 2018, 10:00 ET Population Council's One-Year Contraceptive Ring Advances to FDA Review

The Population Council today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its one-year Nestorone® / ethinyl...


Jan 03, 2018, 09:00 ET New FDA MR-Conditional Labeling Approvals Further Expand Abbott's Portfolio of MRI-Ready Devices

Abbott (NYSE: ABT) today announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for the Quadra...


Jan 03, 2018, 09:00 ET Inova Diagnostics Receives FDA Clearance for the First Fully Automated, Random Access Calprotectin Test

Inova Diagnostics, a world leader in autoimmune disease diagnostic systems and reagents for the clinical laboratory, is proud to announce the...


Jan 03, 2018, 08:09 ET Perrigo Announces Tentative FDA Approval For The Generic Version Of Prolensa® Ophthalmic Solution 0.07%

Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received tentative approval from the U.S. Food and Drug Administration for the...


Jan 03, 2018, 08:00 ET Landmark Schizophrenia Data That Bring Hope in Breaking the Cycle of Hospitalization and Incarceration Receive FDA Approval for Inclusion in INVEGA SUSTENNA® (paliperidone palmitate) Label

Janssen Pharmaceuticals, Inc., today announced INVEGA SUSTENNA® (paliperidone palmitate), a once-monthly schizophrenia treatment, is the first and...


Jan 03, 2018, 07:15 ET Novartis Kisqali® received FDA Breakthrough Therapy designation for initial endocrine-based treatment in premenopausal women with HR+/HER2- advanced breast cancer

Novartis today announced Kisqali® (ribociclib) received US Food and Drug Administration (FDA) Breakthrough Therapy designation for initial...


Dec 29, 2017, 10:47 ET Mylan Adds to U.S. Women's Healthcare Portfolio With FDA Approval of First Generic for Estrace® Cream

Global pharmaceutical leader Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Estradiol Vaginal Cream USP, 0.01%, the first...


Dec 28, 2017, 13:57 ET FDA permits marketing of device to treat diabetic foot ulcers

Today, the U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat...