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

12 Jun, 2017, 09:05 BST FDA Approves BioMarin's Manufacturing Facility Located in Shanbally, Cork, Ireland

Ongoing Expansion of Facility Furthers Commitment to Irish Manufacturing BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today The...


12 Jun, 2017, 06:30 BST New Immunoassay for Detection of Buprenorphine and Three Major Metabolites

Thermo Scientific™ CEDIA® Buprenorphine II Assay received FDA 510(k) clearance and CE Mark EuroMedLab -- A new immunoassay for the specific...


08 Jun, 2017, 22:54 BST Endo Response to June 8, 2017 FDA Meeting Related to OPANA® ER

Endo International plc (NASDAQ: ENDP) is aware of today's announcement by the U.S. Food and Drug Administration (FDA) requesting that Endo...


06 Jun, 2017, 10:30 BST OrbusNeich Announces FDA Clearance, Launch of Coronary Dilatation Catheters

Announcement marks company's official entry into the US market OrbusNeich, a global company specializing in the provision of life-changing...


01 Jun, 2017, 15:05 BST Roche announces FDA approval of companion diagnostic to identify ALK-positive non-small cell lung cancer patients

- More than 1.6 million people die globally from lung cancer each year.1 - ALK – anaplastic lymphoma kinase – is an important...


01 Jun, 2017, 14:00 BST GenePOC Announces FDA Clearance for Revogene™ Instrument and its GBS LB Test

GenePOC announces it received 510(k) clearance from the US Food and Drug Administration to market its first molecular assay to detect Group B...


31 May, 2017, 21:05 BST Jazz Pharmaceuticals Announces FDA Acceptance of NDA for VYXEOS™ (CPX-351), an Investigational Treatment for Acute Myeloid Leukemia, with Priority Review Status

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


30 May, 2017, 10:00 BST Chinese Infant Milk Powder Won Three Successive Gold Awards in "Monde Selection"

People.cn recently launched a report on Feihe awarded the 2017 "Monde Selection" champion. The full report is as follow: The 2017 award ceremony...


30 May, 2017, 08:00 BST AMO Pharma Announces FDA Fast Track Designation For AMO-02 For Treatment Of Congenital Myotonic Dystrophy

AMO Pharma Limited ("AMO Pharma"), a privately held biopharmaceutical company focusing on debilitating diseases with limited or no treatment...


26 May, 2017, 16:15 BST PV (Pharmacovigilance) Audit Strategy Planning Workshop: Understand the Requirements for a Risk Based Audit Program and Current Interpretation (San Francisco, CA, United States - November 9-10, 2017) - Research and Markets

Research and Markets has announced the addition of the "PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and...


26 May, 2017, 16:00 BST Quality Control Laboratory Compliance Seminar with Focus on cGMPs and GLPs (San Francisco, CA, United States - November 9-10, 2017) - Research and Markets

Research and Markets has announced the addition of the "Quality Control Laboratory Compliance - cGMPs and GLPs: One and a Half-day In-person...


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,...