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 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...


Mar 06, 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...


Mar 06, 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...


Mar 03, 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...


Mar 03, 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...


Mar 03, 2017, 09:00 ET Trust, Transparency and Technology Sets the Stage at the 2017 Global Food Safety Conference

The 16th annual global food safety conference proved to be record-breaking on several dimensions. Nearly 1200 delegates from 54 countries trekked...


Mar 03, 2017, 08:22 ET Confiance, transparence et technologie sont les bases de la Conférence internationale sur la sécurité alimentaire 2017

La 16e Conférence mondiale annuelle sur la sécurité alimentaire a démontré qu'elle pouvait battre des records à plusieurs égards. Près de 1 200...


Mar 02, 2017, 15:34 ET Truth Initiative and Campaign for Tobacco-Free Kids: FDA/Santa Fe Natural Tobacco Agreement Fails to Protect the Public from Misleading Claims and Imagery on Natural American Spirit Cigarettes

Truth Initiative and the Campaign for Tobacco-Free Kids today criticized as wholly inadequate an agreement reached between the Food and Drug...


Mar 02, 2017, 08:03 ET EnGeneIC Receives FDA Orphan Drug Designation for Targeted EDV™ Nanocells to Treat Glioblastoma Multiforme

EnGeneIC Ltd., a clinical stage biopharmaceutical company focused on developing its proprietary EDV™ nanocell platform for targeted...


Mar 02, 2017, 07:00 ET Compugen Announces Presentations of COM701 Immuno-oncology Pipeline Product and Predictive Discovery Methodology for Novel Immune Checkpoints at AACR

Compugen Ltd. (NASDAQ: CGEN), a leading therapeutic discovery company, announced today that two abstracts, the first covering data of its lead...


Mar 02, 2017, 02:41 ET Sobi™ Receives Approval From the European Medicines Agency for Higher capacity Drug Substance Manufacturing for Elocta®

Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) has received approval from the European Medicines Agency (EMA) for the grouped type II 15 K...