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

Apr 23, 2019, 23:02 ET NeuroSigma Announces FDA Clearance of Monarch eTNS System as First Non-Drug Treatment for Pediatric ADHD

NeuroSigma, Inc., a Los Angeles-based bioelectronics company focused on commercializing Trigeminal Nerve Stimulation (TNS) technology for treating...


Apr 23, 2019, 18:19 ET AbbVie Expands Immunology Portfolio in the U.S. with FDA Approval of SKYRIZI™ (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis

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


Apr 23, 2019, 17:17 ET Boston Scientific Receives FDA Approval for LOTUS Edge™ Aortic Valve System

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


Apr 23, 2019, 09:00 ET FDA Grants First-Ever Clearances to Detect Bradycardia and Tachycardia on a Personal ECG Device

AliveCor, the leader in FDA-cleared consumer electrocardiogram technology (ECG), today announced two additional FDA 510(k)-cleared indications,...


Apr 23, 2019, 09:00 ET Rapid Medical Raises $20 Million in New Funding to Support Clinical and Commercialization of First-in-class Stroke Treatment Products

Rapid Medical, a company focused on the development of interventional neurovascular devices, announced today that it has completed an oversubscribed...


Apr 23, 2019, 07:00 ET BAROnova Announces FDA Approval of the TransPyloric Shuttle® (TPS®) Device

BAROnova, Inc., a medical device company focused on the development of first-in-class non-surgical solutions for the treatment of obesity, announced...


Apr 23, 2019, 04:00 ET Rapid Medical beschafft Neufinanzierung in Höhe von 20 Millionen USD für klinische Studien und Vermarktung des erstens Produkts seiner Klasse zur Schlaganfallbehandlung

Rapid Medical, ein Unternehmen, das auf die Entwicklung von Medizinprodukten zur interventionellen Behandlung neurovaskulärer Erkrankungen...


Apr 23, 2019, 04:00 ET Rapid Medical recueille 20 millions de dollars US à l'occasion d'un nouveau cycle de financement pour soutenir les essais cliniques et la commercialisation de produits de traitement de premier ordre contre les AVC

Rapid Medical, une société spécialisée dans le développement de dispositifs d'intervention neurovasculaire, a annoncé aujourd'hui la finalisation...


Apr 19, 2019, 11:15 ET FDA approves first generic naloxone nasal spray to treat opioid overdose

The U.S. Food and Drug Administration today granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, ...


Apr 18, 2019, 07:30 ET Moleculin Receives FDA Approval of Fast Track Designation for Annamycin

Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug...


Apr 18, 2019, 07:00 ET Beckman Coulter's Early Sepsis Indicator Receives 510(k) Clearance from the U.S. Food and Drug Administration

A major milestone on its strategic mission to lead in sepsis diagnostics, Beckman Coulter today announced that its Early Sepsis Indicator has...


Apr 16, 2019, 12:21 ET 17 de abril - Dia Mundial da Hemofilia

O dia 17 de abril é extremamente importante para a comunidade de mais de 12 mil brasileiros que vivem com hemofilia no país. O Dia Mundial da...


Apr 16, 2019, 08:00 ET Aquestive Therapeutics Announces U.S. Food and Drug Administration (FDA) Acceptance of New Drug Application for Riluzole Oral Film for Treatment of ALS

Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products to...


Apr 16, 2019, 06:00 ET Aprea Therapeutics Receives FDA Fast Track Designation and Orphan Drug Designation for APR-246 for the Treatment of Myelodysplastic Syndromes (MDS)

Aprea Therapeutics, a privately held, clinical stage biopharmaceutical company developing novel anticancer therapies targeting the tumor suppressor...


Apr 15, 2019, 16:05 ET Novartis announces FDA filing acceptance and Priority Review of brolucizumab (RTH258) for patients with wet AMD

Novartis announced that the U.S. Food and Drug Administration (FDA) accepted the company's Biologics License Application (BLA) for brolucizumab...


Apr 15, 2019, 16:00 ET EVENITY™ (romosozumab-aqqg) Now Available In The United States For The Treatment Of Osteoporosis In Postmenopausal Women At High Risk For Fracture

Amgen (NASDAQ: AMGN) today announced that EVENITY™ (romosozumab-aqqg) is now available for shipment to wholesalers in the U.S. EVENITY was approved...


Apr 12, 2019, 14:08 ET BALVERSA™ (erdafitinib) Receives U.S. FDA Approval for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma with Certain FGFR Genetic Alterations

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that BALVERSA™ (erdafitinib) received accelerated approval from the U.S....


Apr 12, 2019, 13:29 ET FDA approves first targeted therapy for metastatic bladder cancer

The U.S. Food and Drug Administration today granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally...


Apr 12, 2019, 11:55 ET The Food and Drug Administration (FDA) Determines that Women Taking Addyi May Safely Consume Alcohol

Sprout Pharmaceuticals is pleased to announce that the FDA has decided that existing warnings and restrictions regarding alcohol use in women taking...


Apr 12, 2019, 10:07 ET FDA Cleared MediPines Gas Exchange Monitor Measures Freedivers' Lung Efficiency in Ground-Breaking Study

Novel physiologic results on world elite freedivers' using the non-invasive MediPines Gas Exchange Monitor (https://bit.ly/2YVAG1M) were presented at ...


Apr 11, 2019, 18:48 ET First AI Enabled ROI Radiation Reduction Shutter Technology FluoroShield™ Cleared by FDA

Omega Medical Imaging announces the launch of FluoroShield™ in conjunction with technology partner IKOMED Technologies, Vancouver, BC Canada....


Apr 11, 2019, 17:00 ET Omron Healthcare Announces April 15th Pre-Order Availability of Complete™, the First Blood Pressure Monitor with EKG Capability

Omron Healthcare, Inc., the global leader in personal heart health and wellness technology, has secured FDA clearance on its new Complete™, the first ...


Apr 10, 2019, 07:46 ET Getinge Receives 510(k) Clearance From US FDA for Software Upgrade in Servo-u® and Servo-n® Ventilator Platform

Getinge is today announcing clearance from the US Food & Drug Administration (FDA) for a new software version for the Servo-u® and Servo-n®...


Apr 10, 2019, 07:30 ET Sound Biologics Announces FDA Allowance of its IND Application for PSB205, an Anti-PD-1/CTLA-4 MabPair, in Relapsed and Refractory Solid Tumors

Qilu Puget Sound Biotherapeutic Corp. (Sound Biologics), an emerging biotechnology company dedicated to developing next generation antibody...


Apr 10, 2019, 07:21 ET RFA-Elektrochirurgiegerät SIRA™ von Innoblative erhält FDA-Zulassung

Innoblative Designs, Inc. (Innoblative), ein privates Medizinprodukteunternehmen, das sich der Entwicklung chirurgischer Lösungen der nächsten...