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

Dec 16, 2016, 09:48 ET FDA Grants QT Vascular Full IDE Approval to Begin Pivotal Trial Of Its Drug-Coated Balloon, Chocolate Touch™

QT Vascular Ltd., (the "Company" or "QT Vascular", and together with its subsidiaries, the "Group"), is a global company engaged in the design,...


Dec 16, 2016, 06:48 ET Grünenthal Receives Breakthrough Therapy Designation From U.S. FDA for Neridronic Acid for the Treatment of CRPS

Grünenthal receives Breakthrough Therapy Designation from U.S. FDA for neridronic acid for the treatment of complex regional pain syndrome...


Dec 15, 2016, 07:00 ET Commercial Patient Data Confirms Success of EnteroMedics' vBloc® Therapy in Combination with vBloc® Achieve Program in Patients Struggling to Lose Weight

EnteroMedics Inc. (NASDAQ:ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and...


Dec 14, 2016, 13:32 ET FDA approves Eucrisa for eczema

The U.S. Food and Drug Administration today approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in...


Dec 14, 2016, 12:00 ET Nintedanib granted orphan drug designation for treatment of mesothelioma

Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to nintedanib for the...


Dec 14, 2016, 09:38 ET Bayer Announces FDA Acceptance of Supplemental Biologics License Application for myBETAapp™ and BETACONNECT™ Navigator

Bayer today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of a supplemental Biologics License Application...


Dec 14, 2016, 09:30 ET Ability Pharmaceuticals Announces Orphan Drug Designation in the US for ABTL0812 in Pancreatic Cancer

Ability Pharmaceuticals, a drug development biopharmaceutical company specialized in oncology, announced today that it has received from the US...


Dec 13, 2016, 17:54 ET FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee

The U.S. Food and Drug Administration today approved Maci (autologous cultured chondrocytes on porcine collagen membrane) for the repair of...


Dec 12, 2016, 15:28 ET U.S. FDA approves Synjardy® XR (empagliflozin/metformin hydrochloride extended-release) tablets for adults with type 2 diabetes

The U.S. Food and Drug Administration (FDA) has approved Synjardy® XR (empagliflozin and metformin hydrochloride extended-release) tablets for...


Dec 12, 2016, 07:55 ET Galderma Announces FDA Approval of Restylane® Refyne and Restylane® Defyne Dermal Fillers for Treatment of "Laugh Lines"

Galderma, a global leader focused on medical solutions in skin health, announced today it has received U.S. Food and Drug Administration (FDA)...


Dec 09, 2016, 09:00 ET Biohaven' BHV-0223 is Granted Orphan Drug Designation in the Treatment of Amyotrophic Lateral Sclerosis

TORONTO, Dec. 9, 2016 /PRNewswire/ - Portage Biotech Inc. ("Portage" or "the Company") (OTC: PTGEF, Canadian Securities Exchange: PBT.U), is...


Dec 09, 2016, 07:28 ET La terapia Stretta para GERD de Mederi recibe su aprobación en China

La solución para la enfermedad de reflujo gastrointestinal clínicamente demostrada y con un coste contenido se ha lanzado recientemente en China...


Dec 09, 2016, 06:29 ET Approvata in Cina la terapia Stretta Mederi per il trattamento della MRGE

Lanciata di recente in Cina la soluzione economica e clinicamente comprovata per il trattamento della malattia da reflusso gastroesofageo (MRGE)....


Dec 08, 2016, 14:54 ET Terapia Stretta da Mederi aprovada para a DRGE na China

A Mederi Therapeutics Inc. anunciou aprovação regulatória, pela CFDA, e lançamento de produto para a terapia Stretta, um tratamento não cirúrgico...


Dec 08, 2016, 13:17 ET AMI's TubeClear® System Receives Additional FDA Clearances

Actuated Medical Inc. (AMI) received U.S. Food and Drug Administration (FDA) Clearance on 3 additional TubeClear System Clearing Stem Models. This...


Dec 08, 2016, 11:23 ET Mederis Stretta-Therapie erhält Zulassung für GERD in China

Klinisch erprobte und kosteneffektive Lösung für gastroösophageale Refluxerkrankung in China eingeführt. Mederi Therapeutics Inc. hat die...


Dec 08, 2016, 08:52 ET Se aprueba la terapia Stretta de Mederi para la GERD en China

Mederi Therapeutics Inc ha anunciado que la CFDA ha dado su aprobación reglamentaria y que se lanzará su producto para la terapia Stretta en China,...


Dec 08, 2016, 08:23 ET La thérapie Stretta de Mederi contre le RGO approuvée en Chine

Solution cliniquement testée et rentable contre le reflux gastro-œsophagien récemment lancée en Chine. Mederi Therapeutics Inc. a...


Dec 08, 2016, 08:00 ET LEVL Registers For FDA Class I Medical Device Taking Wellness Community One Breath Closer to Fat-Loss Revolution

LEVL, an exciting new health and wellness device announced today that it is now classified as a FDA Class I medical device. This is a critical next...


Dec 08, 2016, 07:00 ET Exact Imaging Receives FDA 510(k) Clearance for Its ExactVu™ Micro-Ultrasound System

New Disruptive Prostate Micro-Imaging and Biopsy System Approved for Commercial Release in the United States TORONTO, Dec. 8, 2016 /PRNewswire/ -...


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