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.

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Sep 20, 2019, 10:49 ET FDA approves Rybelsus® (semaglutide), the first GLP-1 analog treatment available in a pill for adults with type 2 diabetes

Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved Rybelsus® (semaglutide) tablets 7 mg or 14 mg for adults...


Sep 20, 2019, 10:42 ET FDA approves first oral GLP-1 treatment for type 2 diabetes

The U.S. Food and Drug Administration today approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with...


Sep 20, 2019, 10:00 ET Hovione Announces Successful End-of-phase 2 Meeting With the FDA and Outlines Phase 3 Program for Minocycline Topical Gel

Hovione announced details of its planned MARS-2 and MARS-3 (Minocycline Against Rosacea Study) Phase 3 development program for the treatment of...


Sep 18, 2019, 16:12 ET Louisiana Eye Doctor Now Performs PanOptix Lens Placement For Cataract Patients

Louisiana Eye and Laser, home to ophthalmologists Dr. Michael Redmond and Dr. Patrick Redmond, performed the first PanOptix Lens replacement...


Sep 18, 2019, 08:00 ET FDA grants Fast Track Designation for SPI-1005 in the Treatment of Meniere's Disease

Sound Pharmaceuticals is pleased to announce that the FDA's Division of Neurology Products has granted its request for Fast Track Designation (FTD)...


Sep 18, 2019, 08:00 ET OrthoSpin Receives FDA Regulatory Clearance

OrthoSpin Ltd. a portfolio company of The Trendlines Group Ltd. ("Trendlines") (SGX: 42T) (OTCQX: TRNLY), announced today that it received regulatory ...


Sep 17, 2019, 20:29 ET U.S. FDA Approves Supplemental New Drug Application (sNDA) for ERLEADA® (apalutamide) for the Treatment of Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved ERLEADA®...


Sep 16, 2019, 09:00 ET SofWave Medical's Low-divergence Ultrasound Technology Has Received FDA Clearance for the Aesthetic Treatment of Facial Lines and Wrinkles

Sofwave Medical Ltd., an emerging aesthetic device company, announced that it has received 510(k) clearance from the U.S. Food and Drug...


Sep 16, 2019, 08:00 ET Glenmark Receives Orphan Drug Designation for GBR 1342, a Bispecific Antibody Candidate Under Evaluation for the Treatment of Multiple Myeloma

Glenmark Pharmaceuticals (Glenmark), a research-led, integrated global pharmaceutical company, today announced that the U.S. Food and Drug...


Sep 16, 2019, 08:00 ET Seattle Genetics and Astellas Announce U.S. FDA Grants Priority Review for Enfortumab Vedotin Biologics License Application in Locally Advanced or Metastatic Urothelial Cancer

Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that...


Sep 16, 2019, 07:10 ET New FDA Clearance Paves The Way to Optimization of Insulin Pump Therapy Across All Glucose Measurement Methods

DreaMed Diabetes, developer of personalized diabetes management solutions, announced today that it has received U.S Food and Drug Administration...


Sep 16, 2019, 07:00 ET Zimmer Biomet Receives FDA Clearance of JuggerStitch™ Meniscal Repair Device

Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, has announced 510(k) clearance from the U.S. Food...


Sep 13, 2019, 13:29 ET LaunchPad Medical erhält FDA-Genehmigung für klinische Studie

LaunchPad Medical, Inc. erhielt die Genehmigung von der US-Arzneimittelbehörde U.S. Food and Drug Administration für eine klinische Pilotstudie an...


Sep 13, 2019, 06:41 ET LaunchPad Medical a reçu l'autorisation de la FDA de lancer une étude clinique

LaunchPad Medical, Inc. a reçu l'autorisation de la U.S. Food and Drug Administration de lancer une étude clinique pilote sur deux sites portant sur...


Sep 13, 2019, 06:33 ET LaunchPad Medical recibe la aprobación de la FDA para iniciar el estudio clínico

LaunchPad Medical, Inc. ha recibido la aprobación de la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) para iniciar un...


Sep 12, 2019, 16:37 ET Qfix® Announces FDA 510(k) Clearance of Encompass™ 15 Channel Head Coil for Siemens 3T MRI Systems

Qfix has received FDA 510(k) clearance for the Encompass 15-Channel Head Coil, a diagnostic imaging device optimized for use with the Encompass™ MR...


Sep 12, 2019, 15:13 ET Ardelyx Receives FDA Approval for IBSRELA® (Tenapanor), an NHE3 Sodium Transport Inhibitor, for the Treatment of Irritable Bowel Syndrome with Constipation

Ardelyx, Inc. (NASDAQ: ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment...


Sep 12, 2019, 13:44 ET LaunchPad Medical Received FDA Approval to Initiate a Clinical Study

LaunchPad Medical, Inc. has received approval from the U.S. Food and Drug Administration to initiate a two-site, 20-patient pilot clinical study to...


Sep 12, 2019, 12:00 ET 3D Systems Draws on Healthcare Expertise to Deliver FDA Cleared D2P™ - Industry's Only Company to Create Patient-Specific, Diagnostic, Anatomic Models Using its Own Software and Printers

3D Systems (NYSE:DDD) announced today it received additional 510(k) clearance for its D2P™ (DICOM-to-PRINT) software allowing clinicians to 3D print...


Sep 12, 2019, 10:16 ET V-Wave Receives Second FDA Breakthrough Device Designation: Interatrial Shunt for Pulmonary Arterial Hypertension

V-Wave Ltd., a privately held medical device company developing novel implantable interatrial shunt devices, today announced that the U.S. Food and...


Sep 12, 2019, 00:05 ET Healthy.io Raises $60 Million in Series C Funding and Receives FDA Clearance for Smartphone-Based Test to Diagnose Chronic Kidney Disease

Today, Healthy.io, the global leader in turning the smartphone camera into a clinical-grade medical device, announced it has received 510(k)...


Sep 11, 2019, 02:30 ET Merck KGaA, Darmstadt, Germany, Announces FDA Breakthrough Therapy Designation for Investigational Therapy Tepotinib in Patients with Metastatic NSCLC with METex14 Skipping Alterations

Not intended for UK-based media DARMSTADT, Germany, Sept. 11, 2019 /PRNewswire/-- Merck KGaA, Darmstadt, Germany, a leading science and technology...


Sep 10, 2019, 17:29 ET Aczone® (dapsone) Gel, 7.5% Now Approved for the Topical Treatment of Acne Vulgaris in Patients 9 Years of Age and Older

Almirall LLC announced today the FDA approval of the expanded indication for Aczone® 7.5% Gel to include patients aged 9-11. Aczone® 7.5% Gel is a...


Sep 09, 2019, 15:56 ET Jenkins Eye Care Offers First and Only FDA-approved Trifocal Lens: AcrySof IQ PanOptix Trifocal IOL

Ophthalmological surgeons Tyrie Jenkins, M.D. and Jeffrey Peterson, M.D., Ph.D., of Jenkins Eye Care, now offer cataract patients a trifocal lens...


Sep 09, 2019, 13:44 ET ANSI National Accreditation Board (ANAB) Accredits Global Standards S.C. (GSSC) to Certify Foreign Food Supplies under U.S. FDA-FSMA Program

The ANSI National Accreditation Board (ANAB), a wholly-owned subsidiary of the American National Standards Institute, has accredited Global Standards ...