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

Mar 16, 2017, 10:00 ET An Important Recognition in the US Market for the WatchPAT™ Device: The American Academy of Sleep Medicine ("AASM") has Formally Endorsed Itamar Medical's WatchPAT™ Technology to Diagnose Sleep Apnea, Based on Published Evidence

Itamar Medical Ltd. (TASE: ITMR) reports that AASM, the leading medical association of sleep medicine physicians in the United States, has...


Mar 16, 2017, 02:00 ET 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,...


Mar 15, 2017, 08:40 ET First Ray Receives FDA 510(k) Clearance for Expanded Stealth Staple™ Product Line

First Ray, a start-up medical device company focused on advanced surgical devices for improving outcomes for orthopaedic extremity procedures,...


Mar 14, 2017, 12:54 ET Colorado unapproved drug and dietary supplement makers ordered to cease operations for federal violations

Yesterday, U.S. District Judge Marcia S. Krieger for the U.S. District Court for Colorado entered a consent decree of permanent injunction against...


Mar 13, 2017, 15:56 ET Novartis Kisqali® (ribociclib, LEE011) receives FDA approval as first-line treatment for HR+/HER2- metastatic breast cancer in combination with any aromatase inhibitor

The US Food and Drug Administration (FDA) has approved Kisqali® (ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor...


Mar 13, 2017, 09:38 ET Forward Progress for Assay Kit Sequencing Approaches in Past Three Months

At this time, most sequencing tests performed for clinical applications in the U.S. are laboratory developed tests (LDTs), according to Kalorama...


Mar 13, 2017, 09:30 ET BiondVax Publishes Regulatory Approval Strategy for Novel Universal Flu Vaccines in Future Virology Journal

BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing...


Mar 13, 2017, 09:00 ET Neurim Pharmaceuticals Paediatric Prolonged-Release Melatonin ('PedPRM') to be Marketed by Biocodex in France

Neurim Pharmaceuticals ('Neurim') announced today that it has entered into a licensing agreement with Biocodex. The agreement grants Biocodex...


Mar 10, 2017, 10:15 ET Duchesnay Expands Its Women's Health Product Portfolio With Acquisition Of Osphena® From Shionogi Inc.

Duchesnay, a specialty pharma company with a long-standing commitment to women's health, has acquired exclusive U.S. and Canadian rights to market...


Mar 10, 2017, 08:00 ET Intec Pharma Announces $10 Million Private Placement

Intec Pharma Ltd. (NASDAQ; TASE: NTEC), a clinical-stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion...


Mar 09, 2017, 09:59 ET Medela Introduces Complete Enteral Feeding System with Launch of New Product

Medela LLC has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market ENFit Low Dose Tip enteral syringes. When used...


Mar 09, 2017, 08:00 ET FDA grants orphan drug designation to Boehringer Ingelheim's investigational anti-CD33 monoclonal antibody BI 836858 for treatment of myelodysplastic syndromes

Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its anti-CD33...


Mar 09, 2017, 08:00 ET eFFECTOR Therapeutics' Lead Product Candidate, eFT508, Receives Orphan Designation from FDA for Treatment of Diffuse Large B-Cell Lymphoma

eFFECTOR Therapeutics today announced that its lead product candidate, eFT508, has been granted orphan drug designation by the U.S. Food and Drug...


Mar 09, 2017, 07:00 ET Exact Imaging Announces Health Canada Approval and License for its ExactVu™ micro-ultrasound system for prostate imaging and biopsy

Sunnybrook Health Sciences Centre with Sunnybrook Research Institute is the first Canadian Customer Site for the ExactVu™ system TORONTO, March...


Mar 08, 2017, 09:01 ET Kitov Announces License Agreement for KIT-302 in South Korea

Definitive agreement grants Kuhnil Pharmaceutical Co. Ltd. an exclusive license to manufacture and market KIT-302 in South Korea Transaction is...


Mar 08, 2017, 08:42 ET PolyPid Announces Receipt of Qualified Infectious Disease Product (QIDP) Designation from FDA for D-PLEX™ in Post-Cardiac Surgery Sternal Infection

PolyPid Ltd., an emerging clinical-stage specialty pharmaceutical company focused primarily on the development of a post-surgical anti-infective...


Mar 08, 2017, 08:00 ET FDA Accepts Supplemental New Drug Application (sNDA) For VRAYLAR (cariprazine)

Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted...


Mar 08, 2017, 08:00 ET Teligent, Inc. Announces FDA Approval Of Clobetasol Propionate Gel, 0.05%

Teligent, Inc. (NASDAQ: TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced it has received approval of the...


Mar 07, 2017, 11:00 ET Beckman Coulter Diagnostics Receives FDA Clearance for its DxC 700 AU Chemistry Analyzer

Beckman Coulter Diagnostics announces FDA clearance and U.S. commercial launch of its new DxC 700 AU chemistry analyzer. The new system brings...


Mar 07, 2017, 10:49 ET Glenmark Pharmaceuticals Receives FDA Clearance of IND for GSP 304

Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) cleared the Company's...


Mar 07, 2017, 10:00 ET Intellijoint Surgical® Announces intellijoint HIP® Anterior Application FDA Clearance

WATERLOO, ON, March 7, 2017 /PRNewswire/ - Intellijoint Surgical® Inc., a privately-held Canadian medical technology company, announces FDA...


Mar 07, 2017, 09:00 ET Bellerophon Therapeutics and Worldwide Clinical Trials Selected as Finalists in 2017 Care Awards

Worldwide Clinical Trials (http://www.worldwide.com) and Bellerophon Therapeutics (http://www.bellerophon.com) have been selected as finalists in...


Mar 07, 2017, 03:11 ET Swedish Orphan Biovitrum AB - FDA Approves in-use Storage at Room Temperature for Orfadin® Capsules

Swedish Orphan Biovitrum AB (publ) (Sobi™) today announces that FDA has approved in-use storage at room temperature (25°C or less) for up to 45...


Mar 06, 2017, 13:55 ET CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] Data Demonstrate Improved Treatment Satisfaction Relative to Patients' Previous Immunoglobulin Therapy

Shire plc (LSE: SHP, NASDAQ: SHPG), the global leader in rare diseases and highly specialized conditions, will present data assessing primary...


Mar 06, 2017, 08:00 ET First patient in Los Angeles to receive FDA-approved corneal cross-linking procedure treated at USC Roski Eye Institute

The first patient in Los Angeles to receive the recently FDA-approved corneal cross-linking (CXL) procedure to help prevent blindness from...