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

Dec 01, 2016, 11:22 ET Helsinn Integrative Care gibt 510(K)-Freigabe der FDA für Medizinprodukt Xonrid®-Gel bekannt

Helsinn Integrative Care, Helsinns Geschäftszweig, der sich auf evidenzbasierte, nicht-pharmazeutische Pflegeprodukte für Krebs konzentriert, gibt...


Dec 01, 2016, 07:05 ET Biostage Receives FDA Orphan Drug Designation for Cellspan™ Esophageal Implant

Biostage, Inc. (Nasdaq: BSTG), ("Biostage" or the "Company"), a biotechnology company developing bioengineered organ implants to treat cancers and...


Dec 01, 2016, 03:00 ET Helsinn Integrative Care Announces 510(K) FDA Clearance for Medical Device Xonrid® Gel

Helsinn Integrative Care, Helsinn's business unit focused on evidence-based, non-pharmaceutical cancer supportive care products, today announces...


Nov 30, 2016, 14:00 ET AbbVie Receives Orphan Drug Designation for Investigational IL-23 Inhibitor Risankizumab from the U.S. Food and Drug Administration for the Treatment of Pediatric Patients with Crohn's Disease

- Orphan Drug Designation program provides orphan status to medications intended for the safe and effective treatment, diagnosis or prevention of...


Nov 30, 2016, 09:25 ET Teligent, Inc. Announces FDA Approval Of Clobetasol Propionate Lotion 0.05%

Teligent, Inc. (NASDAQ: TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced it has received approval of the...


Nov 30, 2016, 08:30 ET CellResearch Corporation Extends Umbilical Cord Tissue Banking Services Across the US through Partnership with University of Colorado, Anschutz Medical Campus and CariCord

CellResearch Corporation Pte Ltd ("CellResearch"), a Singapore-based company that specializes in stem cell technology, through its wholly owned...


Nov 29, 2016, 14:32 ET FDA Approves Major Advance in Implant Dentistry - Rodo® Abutment System by Rodo Medical, Inc.

Rodo Medical, Inc., an innovative dental device company, announces FDA clearance of the Rodo Abutment System, featuring the shape-memory Smileloc®...


Nov 29, 2016, 08:17 ET FDA Accepts the Biologics License Application for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma for Priority Review

- If approved by the FDA, avelumab, an investigational immunotherapy, could be the first treatment indicated for patients with...


Nov 29, 2016, 08:00 ET Vtesse Receives Rare Pediatric Disease Designation by the FDA for VTS-270 for the Treatment of Niemann-Pick Type C1 Disease

Vtesse, Inc., a company committed to developing medicines to benefit patients with ultra rare, life-threatening diseases, announced today that the...


Nov 28, 2016, 15:45 ET Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval for Armodafinil Tablets (CIV) in 50mg, 150mg and 250 mg strengths (Nuvigil®)

Breckenridge Pharmaceutical, Inc. announced today that it has launched its ANDA for Armodafinil tablets (CIV) in 50mg, 150mg and 250mg strengths on...


Nov 28, 2016, 10:00 ET Global Health Solutions Announces 510k FDA Approval of PolyPlex Wound Dressing

Global Health Solutions has announced 510k FDA approval of PolyPlex Wound Dressing, a first of its kind, petrolatum based topical gel indicated for...


Nov 28, 2016, 09:00 ET Nature Cell Co., Ltd. Receives U.S. FDA Approval for Phase I and II Alzheimer's Clinical Trial

Nature Cell Co., Ltd. (Nature Cell) (CEO, Dr. Jeongchan Ra), a leading biotechnology company, announces AstroStem's approval for Phase I and Phase...


Nov 28, 2016, 08:30 ET PhaseRx Receives Orphan Drug Designation from FDA for PRX-OTC for the Treatment of Ornithine Transcarbamylase Deficiency

PhaseRx, Inc. (NASDAQ: PZRX), a biopharmaceutical company developing mRNA treatments for life-threatening inherited liver diseases in children,...


Nov 28, 2016, 08:08 ET BiondVax Announces Third Quarter 2016 Financial Results and Update

BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing a...


Nov 28, 2016, 06:54 ET Lannett Announces Approval For Metaxalone Tablets USP, 800 Mg

Lannett Company, Inc. (NYSE: LCI) today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New...


Nov 25, 2016, 14:43 ET DILON Diagnostics and GE Healthcare announce the FDA clearance of the Discovery NM 750b biopsy accessory

DILON Diagnostics and GE Healthcare are pleased to announce the FDA clearance of the Molecular Breast Imaging (MBI) localization accessory for...


Nov 22, 2016, 16:39 ET USC Roski Eye Institute director helps breakthrough glaucoma treatment come to the U.S. as Allergan receives FDA clearance for XEN® gel stent

Millions of glaucoma patients whose previous surgical treatment failed to reduce their eye pressure have new hope following several years of...


Nov 22, 2016, 11:07 ET Lipogems Announces New FDA Clearance

Lipogems, a leading international tissue repair company, today announced the U.S. Food and Drug Administration 510(k) clearance for expanded...


Nov 22, 2016, 07:35 ET Allergan Receives FDA Clearance for the XEN® Gel Stent, a New Surgical Treatment for Refractory Glaucoma

Allergan plc (NYSE: AGN) announced today the U.S. Food and Drug Administration (FDA) has cleared the XEN® Glaucoma Treatment System (consisting of...


Nov 22, 2016, 07:00 ET Highly Pathogenic Bird Flu Spreading Across Europe and Asia; BiondVax’s Universal Flu Vaccine Candidate Also Covers these Potential Pandemic Strains

The first cases of highly pathogenic H5N6 Avian Influenza ("Bird Flu") were confirmed last week in South Korea[1]. Over 62,000 birds have been...


Nov 22, 2016, 07:00 ET BCM-95® Targets Anxiety and Depression; Positive Results for Natural Dosing of Curcumin for Depression

A new clinical study confirms positive effects of BCM-95®, a high-potency turmeric extract in treating Major Depressive Disorder (MDD) and...


Nov 21, 2016, 19:51 ET Novo Nordisk Receives FDA Approval for Xultophy® 100/3.6 (insulin degludec and liraglutide injection)

Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application...


Nov 21, 2016, 19:19 ET Sanofi Receives FDA Approval of Soliqua™ 100/33 for the Treatment of Adults with Type 2 Diabetes

Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved once-daily Soliqua™ 100/33 (insulin glargine & lixisenatide...


Nov 21, 2016, 16:37 ET DARZALEX® (daratumumab) Approved by U.S. FDA in Combination with Two Standard of Care Regimens for the Treatment of Patients with Multiple Myeloma Who Have Received At Least One Prior Therapy

Janssen Biotech, Inc. announced today the U.S. Food and Drug Administration (FDA) has approved DARZALEX® (daratumumab) in combination with...


Nov 21, 2016, 10:30 ET International Isotopes Inc. Submits Abbreviated New Drug Application For Sodium Iodide I-131

International Isotopes Inc. (OTCQB: INIS) (the "Company") announces that it has submitted an abbreviated new drug application (aNDA) to the U.S....