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

23 Mar, 2017, 08:30 ET Gamida Cell Receives Additional EMA Orphan Drug Designation for NiCord® in Haematopoietic Stem Cell Transplantation (HSCT)

Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, announced today that orphan drug...


23 Mar, 2017, 08:00 ET Symbiomix Therapeutics Announces FDA's Acceptance of New Drug Application for Solosec™ with Priority Review Status

Symbiomix today announced that the US Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for its...


23 Mar, 2017, 07:30 ET Medicure Announces FDA Approval for Apicore's Generic Tetrabenazine

WINNIPEG, March 23, 2017 /PRNewswire/ - Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a leading Canadian specialty...


23 Mar, 2017, 07:00 ET BioLineRx Announces Acquisition of Agalimmune Ltd. to Accelerate Expansion of Immuno-Oncology Pipeline

BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, announced today that it has...


22 Mar, 2017, 09:00 ET Newton-Wellesley Hospital's Early Detection Initiative Improves Clinical Outcomes, Reduces Nurse Alarm Response Time by 59%

EarlySense, the market leader in Contact-Free Continuous Monitoring solutions, announced today that Newton-Wellesley Hospital, a nationally...


21 Mar, 2017, 15:17 ET FDA approves drug to treat Parkinson's disease

The U.S. Food and Drug Administration today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson's disease who...


21 Mar, 2017, 09:00 ET Tarrex Biopharma Announces FDA Acceptance of IND Application for TX803 to Commence Phase I Clinical Trials in Colorectal Cancer Patients

Tarrex Biopharma, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's Investigational New Drug (IND)...


20 Mar, 2017, 13:14 ET Mylan Receives Tentative Approval for "TLE400" Under PEPFAR

Mylan N.V. (NASDAQ, TASE: MYL), a leading global pharmaceutical company, today announced receipt of tentative approval from the U.S. Food and Drug...


20 Mar, 2017, 08:00 ET Trovita Health Science Announces FDA Marketing Clearance of New SAFE-T FEED™ Nutrition Delivery Device for Tube Feeding

Trovita Health Science, an emerging life science company specializing in medical nutrition, announces U.S. Food and Drug Administration marketing...


20 Mar, 2017, 07:31 ET JUVÉDERM VOLLURE™ XC Approved by U.S. FDA for Correction of Facial Wrinkles and Folds in Adults over the Age of 21

Allergan plc, (NYSE: AGN), a leading global pharmaceutical company, today announced that the company has received approval from the U.S. Food and...


20 Mar, 2017, 07:00 ET BioLineRx Provides Update on Phase 2 Open-Label Study for BL-8040 as Novel Stem Cell Mobilization Treatment

- Results to date confirm that single injection of BL-8040 mobilizes sufficient amounts of cells required for allogeneic transplantation without...


16 Mar, 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...


16 Mar, 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,...


15 Mar, 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,...


14 Mar, 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...


13 Mar, 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...


13 Mar, 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...


13 Mar, 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...


13 Mar, 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...


10 Mar, 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...


10 Mar, 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...


09 Mar, 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...


09 Mar, 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...


09 Mar, 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...


09 Mar, 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...