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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Jan 07, 2021, 07:02 ET Respicardia Announces Highmark Coverage for the remedē? System in Patients with Central Sleep Apnea

Respicardia, Inc., the manufacturer of the only FDA-approved active implantable system for the treatment of central sleep apnea (CSA), announced...


Jan 07, 2021, 02:20 ET UNION therapeutics A/S receives FDA approval for IND of oral next generation PDE4-inhibitor (orismilast) for investigation in plaque psoriasis

UNION therapeutics A/S (UNION) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND)...


Jan 06, 2021, 06:00 ET Ultromics receives FDA Clearance for a first-of-kind solution in Echocardiography to help clinicians diagnose disease

A world-first, AI powered, outcomes-driven, decision support tool – EchoGo Pro, has been cleared by the FDA and is now available to clinicians across ...


Jan 05, 2021, 09:00 ET FoodChain ID Acquires Viaware

FoodChain ID, a market-leading provider of technology-enabled food safety, quality, and sustainability solutions, has acquired Viaware, a leading...


Jan 05, 2021, 08:05 ET Precigen Announces Clearance of IND to Initiate Phase I Study of PRGN-2012 AdenoVerse? Immunotherapy in Patients with Recurrent Respiratory Papillomatosis (RRP)

Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives ...


Jan 05, 2021, 07:30 ET Accuray Receives 510(k) FDA Clearance for ClearRT? Helical kVCT Imaging for the Radixact? Treatment Delivery System

Accuray Incorporated (NASDAQ: ARAY) announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA)...


Jan 04, 2021, 16:43 ET SCONE Medical Receives FDA Emergency Use Authorization for Novel Aerosol Infection Containment Device

As the world faces a new era of emerging and re-emerging infectious diseases, new technologies are paving the way for safer, more effective treatment ...


Jan 04, 2021, 09:00 ET Bioniz Announces Positive End of Phase 2 Meeting with the FDA for BNZ-1 for the Treatment of Refractory Cutaneous T-Cell Lymphoma

Bioniz Therapeutics, Inc., ("Bioniz"), a clinical-stage biopharmaceutical company advancing a pipeline of first-in-class peptide-based multi-cytokine ...


Jan 04, 2021, 08:00 ET FDA Grants ARX788 Fast Track Designation for HER2-positive Metastatic Breast Cancer

Ambrx announced that the U.S. Food and Drug Administration (FDA) granted ARX788 Fast Track Designation as monotherapy for the treatment of advanced...


Dec 30, 2020, 11:28 ET Micro-Tech Endoscopy and Interscope Announce Partnership & Extended FDA Clearance for EndoRotor? System

Micro-Tech Endoscopy and Interscope inked a partnership agreement to collaborate and distribute the EndoRotor System for interventional...


Dec 29, 2020, 10:00 ET ZetrOZ Systems' Wearable Ultrasound Device, SAM, Receives Expanded FDA Re-Approval, Positioning the Company for Market Growth in 2021

ZetrOZ Systems, developers of the Sustained Acoustic Medicine (SAM) wearable ultrasound, an FDA-cleared bio regenerative medical device, is the...


Dec 29, 2020, 08:00 ET Miraflora Earns USDA Certification for Colorado Farm

Driven to help people be their best naturally through the unique properties of the hemp plant, Miraflora has received USDA Organic Certification for...


Dec 28, 2020, 18:25 ET FDA Approves First Generic of Drug Used to Treat Severe Hypoglycemia

Today, the U.S. Food and Drug Administration approved the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for...


Dec 24, 2020, 09:33 ET Interscope Announces FDA De Novo Marketing Authorization of the EndoRotor? System for Direct Endoscopic Necrosectomy (DEN)

Interscope, Inc. announced today the receipt of FDA de novo clearance to market its EndoRotor? System in the United States for direct endoscopic...


Dec 24, 2020, 08:56 ET El sistema de válvulas bicaval transcatéter TricValve? recibe la designación como dispositivo revolucionario por la FDA

P+F Products + Features GmbH ha recibido la designación como dispositivo revolucionario para el producto líder de la compa?ía, el TricValve?...


Dec 24, 2020, 08:54 ET TricValve? Transkatheter Bicaval Valves System von der U.S. Food and Drug Administration (FDA) als Breakthrough Device ausgezeichnet

Die P+F Products + Features GmbH hat am 15. Dezember 2020 von der U.S. Food & Drug Administration den Status als Breakthrough Device für das...


Dec 24, 2020, 08:52 ET Le système de valves bicavales de transcathéter TricValve? est désigné comme dispositif révolutionnaire par la Food and Drug Administration (FDA) américaine

P+F Products + Features GmbH a re?u la désignation de dispositif de percée pour le produit phare de la société, le système de valves bicavales à...


Dec 23, 2020, 10:33 ET The American FDA Awards The Cetylated Esters Patented By PharmaNutra Gras Substance Recognition

PharmaNutra S.p.A. (the "Company"), specialised in iron-based nutritional supplements and in medical devices for muscles and joints, communicates...


Dec 23, 2020, 10:00 ET FDA Approves Bracco Diagnostics Inc.'s ProHance? (Gadoteridol) Injection, 279.3 mg/mL, for Pediatric Patients Younger than Two Years

Bracco Diagnostics Inc., the U.S subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announced...


Dec 23, 2020, 07:30 ET IMBRUVICA? (ibrutinib) U.S. Prescribing Information Updated to Include Long-Term Data for Waldenstr?m's Macroglobulinemia (WM)

AbbVie (NYSE: ABBV) announced today that the U.S. Food and Drug Administration (FDA) approved the update of the IMBRUVICA? (ibrutinib) Prescribing...


Dec 22, 2020, 09:46 ET TricValve? Transcatheter Bicaval Valves System granted Designation as Breakthrough Device by the U.S. Food and Drug Administration (FDA)

P+F Products + Features GmbH has been granted designation as a Breakthrough Device for the company's lead product, the TricValve? Transcatheter...


Dec 22, 2020, 09:42 ET Nephron Announces FDA Approval of Ketorolac, Signaling New Phase of Growth

Nephron Pharmaceuticals Corporation is celebrating another milestone. The company today announced Food and Drug Administration (FDA) approval of the...


Dec 21, 2020, 21:00 ET SCONE Medical Solutions Inc. Receives Emergency Use Authorization for Self-Contained Negative Pressure Environment

SCONE Medical Solutions Inc. announced today that their product, the Self-Contained Negative Pressure Environment (SCONE?) has been cleared by FDA...


Dec 21, 2020, 14:40 ET SCONE Medical Solutions Inc Receives FDA Emergency Use Authorization (EUA) for Self-Contained Negative Pressure Environment (SCONE?)

SCONE Medical Solutions Inc., a Phoenix-based MedTech startup, has pioneered a new strategy for PPE in healthcare facilities, aimed at reducing the...


Dec 21, 2020, 13:00 ET The Hanover Insurance Group, Inc. to Issue Fourth Quarter Financial Results on February 3

The Hanover Insurance Group, Inc. (NYSE: THG) expects to issue its fourth quarter and full-year financial results after the market closes on...