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 FDA Approval

16 May, 2017, 14:47 BST Glucose Meter Connecting Diabetes Patients To Trusted Care Team Approved In U.S. And Europe

iGlucose® Monitoring System Provides Texting, eMail, and Secure Real-Time Cloud Communication of Diabetes Results and Data Between Person with...


15 May, 2017, 15:28 BST Resverlogix Receives Approval From the FDA Cardiovascular and Renal Division to Proceed With a Requested Apabetalone Clinical Trial

Apabetalone expands to a second major clinical indication in kidney dialysis patients Resverlogix Corp. ("Resverlogix" or the "Company")...


11 May, 2017, 11:00 BST NDS receives FDA clearance for ZeroWire Mobile battery-powered display stand

NDS today announced it has received FDA 510(k) clearance for its new ZeroWire® Mobile battery-powered display stand solution. Designed to enable...


11 May, 2017, 08:01 BST Leica Biosystems Applauds FDA Primary Diagnosis Clearance as a Step Forward in Clinical Acceptance of Digital Pathology

The digital pathology industry just took another step forward, with the FDA clearance of a whole slide imaging (WSI) system (Philips IntelliSite™...


10 May, 2017, 08:00 BST Bridge Therapeutics to Present at BioTrinity 2017 Conference in London

CEO Dr. Greg Sullivan to introduce Bridge and its investigational drug BT-205 to investors and industry executives Bridge Therapeutics, Inc.,...


02 May, 2017, 20:52 BST Roche receives FDA approval for complementary PD-L1 (SP263) biomarker test in urothelial carcinoma

Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced approval of the VENTANA PD-L1 (SP263) Assay by the US Food and Drug Administration (FDA) as a...


26 Apr, 2017, 06:00 BST Shire Granted EU Conditional Marketing Authorisation for Natpar[®▼] (Parathyroid Hormone) for the Treatment of Patients with Chronic Hypoparathyroidism

Natpar is the first and only licensed recombinant human parathyroid hormone therapy for chronic hypoparathyroidism Shire plc (LSE: SHP,...


11 Apr, 2017, 06:39 BST CORRECTION - APAC Biotech Pvt. Ltd: Indian FDA Approves the First Autologous Dendritic Cell-based Immuno-oncology Product, APCEDEN®

A first-of-its-kind Indian biotechnology company, APAC Biotech, was granted with a commercial license by Indian FDA (CDSCO - Central Drugs Standard...


06 Apr, 2017, 17:38 BST New OTC Medical Device Tackles the Growing Demand for Noninvasive Vaginal Rejuvenation Solutions

Joylux debuts vSculpt®, a revolutionary device to address the discomfort and embarrassment suffered by millions of women with pelvic floor...


06 Apr, 2017, 01:00 BST Indian FDA Approves the First Autologous Dendritic Cell-based Immuno-oncology Product, APCEDEN®

A first-of-its-kind Indian biotechnology company, APAC Biotech, was granted with a commercial license by Indian FDA (CDSCO - Central Drugs...


05 Apr, 2017, 13:00 BST Indian FDA Approves the First Autologous Dendritic Cell-based Immuno-oncology Product, APCEDEN®

A first-of-its-kind Indian biotechnology company, APAC Biotech, was granted with a commercial license by Indian FDA (CDSCO - Central Drugs...


05 Apr, 2017, 01:00 BST China FDA Accepts JHL's First Clinical Trial Application

JHL Biotech Inc. (Stock Code: 6540.TWO) is announcing that its Clinical Trial Application ("CTA") for use of JHL1101 in Phase 1 and Phase 3...


30 Mar, 2017, 09:41 BST INTUNIV® (Guanfacine Hydrochloride Prolonged Release), a Non-stimulant for the Treatment of ADHD, Receives Approval in Japan

A New Non-stimulant Clinical Option for Children and Adolescents From 6 to 17 Years old With ADHD Shire plc (LSE: SHP, NASDAQ: SHPG) today...


16 Mar, 2017, 06:00 GMT Shire Receives European Approval for Label Extension of CINRYZE®▼(C1 inhibitor [human]) to Prevent and Treat Hereditary Angioedema (HAE) Attacks in Paediatric Patients with HAE

CINRYZE is now the first and only Hereditary angioedema treatment approved for routine prevention in paediatrics Shire plc (LSE: SHP,...


14 Mar, 2017, 21:29 GMT UK Patients Granted Early Access to Sanofi's Innovative Dermatology Treatment Dupilumab by MHRA

PRESS RELEASE - CORRECTION Positive scientific opinion under Early Access to Medicines Scheme (EAMS) recognises burden of severe atopic...


14 Mar, 2017, 17:27 GMT EuroBloodNet Aims for Better Care for Patients with Rare Blood Disorders

Patients suffering from rare blood disorders will benefit from networks of excellence across the European Member States. At the third...


01 Mar, 2017, 23:36 GMT ALK Announces FDA Approval for its House Dust Mite Sublingual Allergy Immunotherapy Tablet (ACARIZAX® in Europe)

ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that the US Food and Drug Administration (FDA) has approved the Biologics License...


28 Feb, 2017, 19:50 GMT GFSI Kicks Off 16th Global Food Safety Conference, Announces Its "G30" Of Food Safety And Releases A Publication Set To Impact Global Food Supply Chains

The Global Food Safety Initiative (GFSI) today held a press conference to launch the 16th Global Food Safety Conference, announce the release of...


15 Feb, 2017, 08:00 GMT The FDA has Approved Tirosint-SOL, Levothyroxine in Liquid Solution for the American Market, IBSA Patent

Clinical Studies have Demonstrated that Tirosint-sol may Overcome Some of the Limitations of Levothyroxine Tablets IBSA announced today that...


03 Feb, 2017, 22:53 GMT Intarcia Announces FDA Filing Acceptance of New Drug Application (NDA) for ITCA 650 for the Treatment of Type 2 Diabetes

Intarcia Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for active review its New Drug...


30 Jan, 2017, 22:38 GMT Endo Announces U.S. FDA Approval of Ephedrine Sulfate Injection, USP

Endo International plc (NASDAQ / TSX: ENDP) announced today that one of its operating companies, Par Pharmaceutical has received final approval...


19 Jan, 2017, 12:00 GMT U.S. FDA Acknowledges Receipt of Shire's New Drug Application for SHP465 for ADHD

Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Class 2 resubmission...


09 Jan, 2017, 18:53 GMT Arterys Receives FDA Clearance For The First Zero-Footprint Medical Imaging Analytics Cloud Software With Deep Learning For Cardiac MRI

Arterys, a pioneer in cloud-based medical imaging software, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to...


09 Jan, 2017, 15:00 GMT Debiopharm Group's Triptorelin 6-month Formulation Receives Approval for the Treatment of Central Precocious Puberty (CPP) in Europe

Triptorelin is the first 6-month formulation treatment registered in the EU for CPP Debiopharm International SA (Debiopharm -...


27 Dec, 2016, 12:00 GMT Shire Announces FDA Approval of Adynovate® [Antihemophilic Factor (Recombinant), Pegylated] for use in Children and Surgical Settings

New FDA-approved indications for ADYNOVATE provides more hemophilia A patients access to proven prophylaxis with a simple, twice-weekly dosing...