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 12, 2017, 11:55 ET GSK achieves approval for Nucala (mepolizumab) for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) for adults in the US

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) as the first...


Dec 12, 2017, 10:27 ET FDA approves first drug for Eosinophilic Granulomatosis with Polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome

The U.S. Food and Drug Administration today expanded the approved use of Nucala (mepolizumab) to treat adult patients with eosinophilic...


Dec 12, 2017, 08:51 ET Allergan Receives FDA Clearance For the CoolSculpting® Treatment To Improve Appearance Of Lax Tissue In The Double Chin

Allergan plc (NYSE: AGN) today announced that the CoolSculpting® treatment is the first and only non-surgical fat reduction technology to be...


Dec 12, 2017, 07:00 ET Only Generic for Kenalog-40 Injection Just Approved: Available through Amneal Biosciences

Amneal Biosciences received approval yesterday for its Triamcinolone Acetonide Injectable Suspension, USP in 40 mg/mL dosage strength. Poised to...


Dec 12, 2017, 06:00 ET AliveCor Granted Patent for Proactive Notification of Possible Heart Arrhythmias

AliveCor, the leader in FDA-cleared personal electrocardiogram (EKG) technology, today announced issuance of a U.S. patent which covers the use of...


Dec 11, 2017, 17:04 ET Boston Scientific Receives U.S. FDA Approval for the Vercise™ Deep Brain Stimulation System

Boston Scientific Corporation (NYSE: BSX) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the...


Dec 11, 2017, 14:40 ET FDA Approves Sanofi's Admelog® (insulin lispro injection)

PARIS, Dec. 11, 2017 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Sanofi's Admelog®, the first follow-on insulin lispro...


Dec 11, 2017, 12:56 ET FDA approves Admelog, the first short-acting "follow-on" insulin product to treat diabetes

The U.S. Food and Drug Administration today approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in...


Dec 11, 2017, 09:00 ET Polaryx Therapeutics Receives Orphan Drug Designation From the US FDA for the Treatment of Neuronal Ceroid Lipofuscinoses With PLX-100

Polaryx Therapeutics, Inc. is a biotech company developing patient-friendly oral small molecule therapeutics for Late Infantile Neuronal Ceroid...


Dec 11, 2017, 08:00 ET Cardiome Highlights Partner SteadyMed's Agreement With FDA On Pathway To Trevyent NDA Resubmission

NDA Expected to be Filed and Accepted by the End of 2018 NASDAQ:CRME TSX:COM VANCOUVER, Dec. 11, 2017 /PRNewswire/ - Cardiome Pharma Corp....


Dec 10, 2017, 11:40 ET New Data for FDA-Approved CAR T Therapy Show Significant Remission Rates in 42% of Non-Hodgkin Lymphoma Patients

A new article published today in The New England Journal of Medicine shows that 42 percent of diffuse large B cell lymphoma patients treated with...


Dec 08, 2017, 07:30 ET Impax Receives Tentative FDA Approval of Generic Coreg CR® (Carvedilol Phosphate) Extended-Release Capsules

Impax Laboratories, Inc. (NASDAQ: IPXL), a specialty pharmaceutical company, today announced it has received tentative U.S. Food and Drug...


Dec 07, 2017, 10:00 ET VitalConnect Secures Fifth U.S. FDA Clearance for Patient Monitoring Device

VitalConnect, Inc., a leader in wearable biosensor technology for wireless monitoring in hospital and remote patient populations, today announced...


Dec 07, 2017, 07:00 ET Camber Spine Announces FDA Clearance Of Spira™-C Open Matrix Cervical Interbody

Camber Spine announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its SPIRA™-C Open...


Dec 06, 2017, 20:00 ET Magnair™ an eFlow® Closed System Nebulizer together with Sunovion's Lonhala™ is the first eFlow technology based product to receive FDA Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

PARI Pharma GmbH, a company focused on the development and commercialization of advanced aerosol delivery systems based on eFlow® Technology,...


Dec 06, 2017, 08:58 ET Sirnaomics' Leading siRNA Therapeutic Candidate, STP705, Granted Orphan Designation for Treatment of Cholangiocarcinoma

Sirnaomics, Inc. (www.sirnaomics.com), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, announced today that...


Dec 06, 2017, 08:08 ET Third Respiratory Assay Now FDA Cleared on Hologic's New Panther Fusion® System

Hologic, Inc. (Nasdaq: HOLX) announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for...


Dec 05, 2017, 18:02 ET ICBII Announces the Filing of Orphan Drug Designation Application for the Use of α-Synuclein-SMART Molecule in the Treatment of Multiple System Atrophy

Innovative California Biosciences International, Inc., ("ICBII"), announced on November 20th the submission of their Orphan Drug Designation...


Dec 05, 2017, 14:04 ET Novo Nordisk Receives FDA Approval of OZEMPIC® (semaglutide) Injection For the Treatment of Adults with Type 2 Diabetes

Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for OZEMPIC® (semaglutide)...


Dec 05, 2017, 10:33 ET Lia Diagnostics Announces FDA Clearance Of The First And Only Flushable, Biodegradable Pregnancy Test

Lia Diagnostics, Inc. yesterday announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for over-the-counter use of the Lia...


Dec 05, 2017, 08:22 ET Merck KGaA, Darmstadt, Germany Announces FDA 510(k) Clearance of Partner Genea Biomedx’s Fertility Benchtop Incubator Geri™

- Expanded Fertility Technology portfolio highlights Merck KGaA, Darmstadt, Germany's commitment to improve fertility treatment...


Dec 05, 2017, 08:00 ET EMD Serono Announces FDA 510(k) Clearance of Partner Genea Biomedx's Fertility Benchtop Incubator Geri™

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the FDA 510(k) clearance of...


Dec 05, 2017, 08:00 ET Genea Biomedx receives FDA 510k clearance for Geri™ incubator

Genea Biomedx today announced the FDA 510k clearance for its benchtop incubator Geri™. Geri™, an innovative continuous embryo monitoring benchtop...


Dec 04, 2017, 11:45 ET Breckenridge Pharmaceutical, Inc. Announces Final Approval of its ANDA Megestrol Acetate Oral Suspension (Megace® ES)

Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration granted final approval for its Abbreviated New Drug...


Dec 04, 2017, 07:30 ET Mylan and Aspen Announce Launch of Generic Busulfex® Injection

Mylan N.V. (NASDAQ, TASE: MYL) and its partner, Aspen (JSE: APN), today announced the U.S. launch of Myleran (busulfan) Injection, 60 mg/10 mL (6...