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

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...


08 Mar, 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...


08 Mar, 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...


08 Mar, 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...


08 Mar, 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...


07 Mar, 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...


07 Mar, 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...


07 Mar, 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...


07 Mar, 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...


07 Mar, 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...


06 Mar, 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...


06 Mar, 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...


06 Mar, 2017, 08:00 ET Teligent, Inc. Announces FDA Approval Of Triamcinolone Acetonide Ointment USP, 0.5%

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


06 Mar, 2017, 08:00 ET PTC Therapeutics Announces FDA Acknowledgment of New Drug Application Filing for Translarna™ for the Treatment of Nonsense Mutation Duchenne Muscular Dystrophy

SOUTH PLAINFIELD, N.J., March 6, 2017 /PRNewswire/-- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the U.S. Food and Drug...


03 Mar, 2017, 17:39 ET La FDA aprueba el primer tratamiento para la micción nocturna frecuente debido a una producción excesiva de orina

La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) aprobó el día de hoy el aerosol nasal...


03 Mar, 2017, 15:05 ET FDA approves first treatment for frequent urination at night due to overproduction of urine

The U.S. Food and Drug Administration today approved Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two times per night...