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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12:00 BST SMART Medical Systems Receives FDA Clearance for Its G-EYE® Colonoscope

SMART Medical Systems Ltd., a developer and manufacturer of innovative endoscopy products, announced that the FDA issued 510(k) clearance for its...


19 May, 2020, 11:00 BST Invivoscribe Announces FDA Approval for Distribution of the LeukoStrat CDx FLT3 Mutation Assay as an IVD Kit in the United States

Invivoscribe to offer the LeukoStrat® CDx FLT3 Mutation Assay as an FDA approved kit with analysis software. In 2017, Invivoscribe's LeukoStrat® CDx...


13 May, 2020, 17:59 BST Hetero Enters Into a Licensing Agreement With Gilead Sciences, Inc. for the Manufacturing and Distribution of "Remdesivir" in 127 Countries, Including India, for COVID-19

Hetero, one of India's leading generic pharmaceutical companies and the world's largest producer of anti-retroviral drugs, announced today that it...


13 May, 2020, 11:29 BST Fluxergy Announces $30 Million to Expand Manufacturing Capacity of Its One-hour Point-of-care Diagnostic Testing System in Response to COVID-19

Irvine, California-based Fluxergy LLC, a diagnostic test company, is making a $30 million investment to expand its capability to scale production of...


12 May, 2020, 08:00 BST Hikma responds to COVID-19 shortage with launch of Propofol Injectable Emulsion, USP

Hikma Pharmaceuticals PLC (Hikma, Group), the multinational pharmaceutical company, announces the launch of Propofol Injectable Emulsion, USP, 20 mL, ...


06 May, 2020, 07:00 BST Antabio Receives QIDP Designation From the U.S. FDA for the Development of MEM-ANT3310, a Novel Broad-Spectrum Combination Therapy Targeting WHO's Priority Pathogens

Antabio SAS, the biopharmaceutical company focused on developing a broad pipeline of antibacterial treatments against life threatening WHO critical...


04 May, 2020, 15:08 BST New Corona Antibody Test Made in Germany "99.8% Accurate"

Roche launched the new serological (antibody-based) test at the company's Penzberg laboratory on Monday, May 4 at a press conference attended by...


30 Apr, 2020, 13:30 BST binx health Announces Second FDA 510(k) Clearance Of Its Molecular Point-Of-Care Infectious Disease Platform

binx health, a leader in infectious disease testing solutions, announced that it has received a second 510(k) clearance from the U.S. Food and Drug...


27 Apr, 2020, 09:52 BST Green Valley Obtains IND Approval from U.S. FDA for Sodium Oligomannate's International, Phase III Clinical Study

On April 8, 2020, Shanghai Green Valley Pharmaceuticals, China received the formal decision letter from the US Food and Drug Administration (FDA) on...


22 Apr, 2020, 00:54 BST Seegene's Allplex™ 2019-nCoV Assay receives FDA Emergency Use Authorization

Seegene, Inc. announced that U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for its Allplex™ 2019-nCoV Assay, a...


21 Apr, 2020, 08:00 BST Genome & Company receives FDA IND clearance for GEN-001, its first anti-cancer microbiome therapeutic

Genome & Company (KONEX: 314130), a biotechnology company developing innovative therapeutics in immune-oncology, announced today that the United...


13 Apr, 2020, 12:54 BST U.S. FDA Grants CytoSorb® Emergency Use Authorization for Use in Patients with COVID-19 Infection

CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat...


07 Apr, 2020, 11:00 BST Rapid Medical Announces Ahead of Schedule Completion of Patient Enrollment for the TIGER Clinical Study for TIGERTRIEVER Thrombectomy Device

Rapid Medical, a company focused on the development of next generation neurovascular interventional devices, has announced that it has completed...


26 Mar, 2020, 14:40 GMT FDA Grants Orphan Drug Designation to APR-OD031 for the Treatment of Phenylketonuria (PKU)

APR Applied Pharma Research s.a. ("APR"), the Swiss pharma company leveraging drug delivery technologies to develop innovative products for niche and ...


26 Mar, 2020, 10:45 GMT RELIEF THERAPEUTICS and NeuroRx, Inc. File FDA IND for Aviptadil to Treat COVID-19-induced Respiratory Distress

RELIEF THERAPEUTICS Holding AG (SIX: RLF) "Relief", together with NeuroRx, a Delaware Corporation. have filed an Investigational New Drug (IND)...


26 Mar, 2020, 06:00 GMT Thermo Fisher Scientific Receives CE Mark for its Diagnostic Test to Detect COVID-19

Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, today announced that it has received the CE mark in the European Union ...


25 Mar, 2020, 20:05 GMT Jazz Pharmaceuticals Announces FDA Acceptance of New Drug Application for JZP-258 for Cataplexy and Excessive Daytime Sleepiness Associated with Narcolepsy

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review the ...


09 Mar, 2020, 09:00 GMT F2G Receives US FDA Orphan Drug Designation for Olorofim

F2G Ltd, a UK- and Austria-based biotech developing novel therapies for life-threatening systemic fungal infections, announced today that the U.S....


09 Mar, 2020, 06:08 GMT Pharming Receives FDA Approval of New Facility for Expansion of RUCONEST® Production

Pharming Group N.V. (Euronext Amsterdam: PHARM) today announced it has also received US Food and Drug Administration (FDA) approval of Pharming's...


06 Mar, 2020, 07:28 GMT Orexo Submits Application for vorvida® to the FDA to Enable Commercialization in the US

Orexo AB (publ), today announces it has submitted an application to the US Food and Drug Administration (FDA) for vorvida® to enable...


27 Feb, 2020, 14:17 GMT FDA Grants Breakthrough Therapy Designation for Debiopharm's Novel Chemo-radio Sensitizer Debio 1143 for Front-line Treatment of Head & Neck Cancer

Debiopharm (www.debiopharm.com), a Swiss-based, global biopharmaceutical company, today announced that the American Food and Drug Administration...


17 Feb, 2020, 07:30 GMT PharmaMar and Jazz Pharmaceuticals Announce FDA Acceptance and Priority Review of New Drug Application for Lurbinectedin in Relapsed Small Cell Lung Cancer

PharmaMar (MSE:PHM) and Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announce that the U.S. Food and Drug Administration (FDA) accepted for filing with...


11 Feb, 2020, 07:00 GMT FDA Grants De Novo Clearance to Bluegrass Vascular Technologies for the Surfacer® Inside-Out® Access Catheter System

Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for...


21 Jan, 2020, 10:00 GMT OBI Pharma Granted U.S. FDA Orphan Drug Designation for the Treatment of Gastric Cancer for Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999

OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug...


14 Jan, 2020, 07:00 GMT Phagenesis Receives FDA Breakthrough Device Designation for Its Phagenyx® System to Accelerate Removal of the Breathing Tube by Treating Neurogenic Dysphagia

Phagenesis Ltd., a pioneering leader in the treatment of dysphagia, is pleased to announce today that the company has received Breakthrough Device...