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.

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May 07, 2018, 13:56 ET FDA permits marketing of new endoscopic device for treating gastrointestinal bleeding

Today, the U.S. Food and Drug Administration permitted marketing of Hemospray, a new device used to help control certain types of bleeding in the...


May 07, 2018, 10:00 ET CardioFocus® Announces FDA Approval Of The Next-Generation HeartLight® Excalibur Balloon™ Designed For The Treatment Of Paroxysmal Atrial Fibrillation*

CardioFocus, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the HeartLight Excalibur Balloon, a...


May 07, 2018, 07:00 ET Salix Receives FDA Approval For PLENVU®, Next Generation 1-Liter Bowel Cleansing Preparation For Colonoscopies

Salix Pharmaceuticals, Ltd. ("Salix"), one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment...


May 07, 2018, 07:00 ET Kindred Biosciences Receives FDA Approval of Mirataz™ (mirtazapine transdermal ointment) for the Management of Weight Loss in Cats

Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced that the...


May 07, 2018, 07:00 ET Norgine anuncia la aprobación de la FDA de Estados Unidos para PLENVU® (NER1006) - preparación de limpieza intestinal de 1 litro basada en PEG para colonoscopia

- Fecha de lanzamiento en Estados Unidos: segunda mitad de 2018 - En Europa, PLENVU® está disponible por medio de Norgine...


May 07, 2018, 07:00 ET Norgine annonce l'approbation de la FDA américaine pour PLENVU® (NER1006) - une préparation de nettoyage de l'intestin d'un litre à base de PEG en vue de la coloscopie

- Date de lancement aux États-Unis : deuxième trimestre 2018 - En Europe, PLENVU® est distribué par Norgine Norgine B.V....


May 07, 2018, 07:00 ET Norgine meldet FDA-Zulassung für PLENVU® (NER1006) - 1-Liter-PEG-basierte Darmreinigungsvorbereitung für die Koloskopie

- US-Starttermin: zweites Halbjahr 2018 -In Europa wird PLENVU® durch Norgine vertrieben Norgine B.V. gab heute bekannt, dass die...


May 06, 2018, 20:00 ET WuXi STA Changzhou Site Passes First U.S. FDA Inspection

The integrated R&D and manufacturing facility is expecting more products to go into commercial production post approval STA...


May 04, 2018, 12:42 ET FDA approves new uses for two drugs administered together for the treatment of BRAF-positive anaplastic thyroid cancer

The U.S. Food and Drug Administration approved Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of...


May 04, 2018, 08:00 ET FDA Grants PaxVax Fast Track Designation for its Chikungunya Vaccine

PaxVax, a leading independent specialty vaccine company, announced today that it has received Fast Track designation from the U.S. Food and Drug...


May 03, 2018, 14:58 ET US FDA Approves Histogen IND for Female Hair Loss Trial

Histogen, Inc., a regenerative medicine company focused on stimulating the body's stem cells to regenerate tissues and restore youthful function,...


May 03, 2018, 09:00 ET Abbott Expands Cardiac Arrhythmias Portfolio with FDA Clearance of Advanced Mapping Catheter

Abbott (NYSE: ABT) today announced U.S. Food and Drug Administration (FDA) clearance of the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™....


May 03, 2018, 08:00 ET Forty Seven, Inc. Granted Fast Track Designation for 5F9 for the Treatment of Diffuse Large B-Cell Lymphoma and Follicular Lymphoma

Forty Seven, Inc., a clinical-stage company focused on developing checkpoint therapies to activate macrophages in the fight against cancer, today...


May 02, 2018, 17:36 ET TRINTELLIX® (vortioxetine) Prescribing Information Now Includes New Data Showing Improvement in Processing Speed, an Important Aspect of Cognitive Function in Acute Major Depressive Disorder (MDD)

Takeda Pharmaceutical Company Limited (Takeda; TSE: 4502) and H. Lundbeck A/S (Lundbeck; LUN.CO, LUN DC, HLUYY) today announced the U.S. Food and...


May 02, 2018, 08:26 ET Bausch + Lomb ULTRA® Contact Lenses Receive FDA Approval for Extended Wear Indication

Lenses Can Be Worn for Up to Six Nights and Seven Days Continuously Bausch + Lomb, a leading global eye health company and wholly owned...


May 02, 2018, 07:30 ET Paradigm Spine Receives FDA Pre-Market Approval (PMA) For First Of Its Kind Disposable Instrument Kit

Paradigm Spine, LLC, a leader in providing motion preservation solutions for the treatment of lumbar spinal stenosis, today announced that the U.S....


May 02, 2018, 07:00 ET REGENXBIO Receives FDA Fast Track Designation for RGX-121 Gene Therapy for the Treatment of Mucopolysaccharidosis Type II

REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene...


May 01, 2018, 18:16 ET Actelion reicht bei US-Arzneimittelzulassungsbehörde FDA Zulassungsantrag zur Indikationsanpassung für OPSUMIT® (Macitentan) zur Behandlung chronisch thromboembolischer pulmonaler Hypertonie (CTEPH) ein

Der Antrag wird unterstützt von Daten aus der MERIT-1-Studie zur Bewertung von OPSUMIT bei Erwachsenen mit inoperabler CTEPH, die signifikante...


May 01, 2018, 16:41 ET Kymriah® (tisagenlecleucel), first-in-class CAR-T therapy from Novartis, receives second FDA approval to treat appropriate r/r patients with large B-cell lymphoma

Novartis today announced the US Food and Drug Administration (FDA) has approved Kymriah® (tisagenlecleucel) suspension for intravenous infusion for...


May 01, 2018, 13:28 ET Actelion dépose une demande supplémentaire de nouveau médicament auprès de la FDA américaine, en vue d'autoriser l'OPSUMIT® (macitentan) pour le traitement de l'hypertension pulmonaire thromboembolique chronique (HTPC)

Ce dépôt est soutenu par les données de l'essai MERIT-1, qui a évalué l'OPSUMIT chez des adultes présentant une HTPC inopérable, et qui a révélé...


May 01, 2018, 13:24 ET Actelion presenta una solicitud de registro de un nuevo fármaco ante la FDA para la aprobación de OPSUMIT® (macitentan)

- Actelion presenta su solicitud de registro de un nuevo fármaco complementario a la Administración de Alimentos y Medicamentos de los Estados...


Apr 30, 2018, 20:38 ET Actelion składa dodatkowy wniosek o rejestrację nowego leku OPSUMIT® (macitentan) w leczeniu przewlekłego zakrzepowo-zatorowego nadciśnienia płucnego (CTEPH) do amerykańskiej Agencji ds. Żywności i Leków FDA

Wniosek poparty został wynikami badań klinicznych MERIT-1, które poddały ocenie lek OPSUMIT u dorosłych pacjentów z nieoperowalnym schorzeniem...


Apr 30, 2018, 16:29 ET Novartis receives FDA approval of Tafinlar® + Mekinist® for adjuvant treatment of BRAF V600-mutant melanoma

Novartis announced today that the US Food and Drug Administration (FDA) has approved Tafinlar® (dabrafenib) in combination with Mekinist®...


Apr 30, 2018, 15:20 ET Spoločnosť Actelion predkladá Americkému úradu pre potraviny a lieky dodatočnú žiadosť o registráciu nového lieku OPSUMIT® (macitentan) na liečbu chronickej tromboembolickej pľúcnej hypertenzie (CTEPH)

Žiadosť sa odvoláva na výsledky klinického skúšania MERIT-1 hodnotiaceho účinnosť OPSUMIT-u u dospelých s neoperovateľnou CTEPH, u ktorých sa...