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

Nov 15, 2017, 10:36 ET Noden Pharma Announces FDA Approval of Tekturna®(aliskiren) Oral Pellets for the Treatment of Hypertension in Adults and Children 6 Years of Age and Older

Noden Pharma DAC, a global specialty pharmaceutical company that is focused on acquiring prescription medicines across a broad range of therapeutic...


Nov 15, 2017, 08:00 ET Alcyone Lifesciences Receives FDA Clearance for the Alivio System for the Treatment of Hydrocephalus

Alcyone Lifesciences, Inc., announced that the U.S. Food and Drug Administration (FDA) cleared the Alivio Ventricular Catheter & Flusher System...


Nov 14, 2017, 19:02 ET FASENRA (benralizumab) Receives US FDA Approval For Severe Eosinophilic Asthma

AstraZeneca (NYSE: AZN) and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration...


Nov 14, 2017, 13:00 ET Roche receives FDA clearance for the VENTANA MMR IHC Panel for patients diagnosed with colorectal cancer

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food & Drug Administration (FDA) clearance of the VENTANA MMR IHC Panel, which provides...


Nov 14, 2017, 07:50 ET MedShape Announces FDA Clearance for the DynaNail® XL

MedShape, Inc., the industry leader in orthopaedic devices using advanced functional materials, announced today that the company has received U.S....


Nov 14, 2017, 00:16 ET Otsuka And Proteus® Announce The First U.S. FDA Approval Of A Digital Medicine System: ABILIFY MYCITE® (aripiprazole tablets with sensor)

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Proteus Digital Health (Proteus) today announce that the United States Food and Drug Administration...


Nov 13, 2017, 19:17 ET FDA approves pill with sensor that digitally tracks if patients have ingested their medication

The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite...


Nov 13, 2017, 08:00 ET EMD Serono Receives FDA Approval for New GONAL-f® RFF Redi-ject® Pen

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, received approval for a redesigned version of...


Nov 13, 2017, 07:35 ET Allergan Receives FDA Approval For Use of VRAYLAR™ (cariprazine) in the Maintenance Treatment of Schizophrenia

Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA)...


Nov 09, 2017, 09:00 ET Northwestern Medicine offers new Minimally Invasive Breakthrough Treatment for Enlarged Prostate

Northwestern Medicine's urology department is excited to announce a minimally invasive treatment option for men with enlarged prostates. The...


Nov 09, 2017, 08:30 ET Stryker receives US FDA HDE approval for the Neuroform Atlas™ Stent System to treat wide neck aneurysms

Stryker Corporation announced today that the U.S. Food and Drug Administration has approved the Neuroform Atlas™ Stent System for marketing under a...


Nov 08, 2017, 17:34 ET DT MedTech Announces 510(k) FDA Clearance for Hintermann Series H2™ Total Ankle Replacement System

DT MedTech, LLC (DTM) today announced that the Hintermann Series H2™ Total Ankle Replacement System has received 510(k) clearance from the U.S....


Nov 07, 2017, 10:58 ET Roche receives FDA approval for VENTANA ALK (D5F3) CDx Assay to identify lung cancer patients eligible for treatment with Roche's ALECENSA (alectinib)

Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced it has obtained US Food and Drug Administration (FDA) approval for the VENTANA ALK (D5F3) CDx...


Nov 06, 2017, 11:40 ET FDA approves first treatment for certain patients with Erdheim-Chester Disease, a rare blood cancer

The U.S. Food and Drug Administration today expanded the approval of Zelboraf (vemurafenib) to include the treatment of certain adult patients with...


Nov 06, 2017, 08:00 ET UCB's VIMPAT® (lacosamide) now approved by FDA to treat partial-onset seizures in pediatric epilepsy patients

- VIMPAT® (lacosamide) CV oral formulations are approved as a monotherapy or adjunctive therapy in patients four years of age and...


Nov 06, 2017, 08:00 ET Artemis Therapeutics Receives Orphan Drug Designation From U.S. Food And Drug Administration For Artemisone For The Treatment Of Malaria

Artemis Therapeutics, Inc. (OTCQB: ATMS), ("Artemis" or the "Company"), a pharmaceutical company developing new therapies for the...


Nov 06, 2017, 07:00 ET Neovasc Receives FDA Approval to Initiate Pivotal Reducer Trial

NASDAQ, TSX: NVCN VANCOUVER, Nov. 6, 2017 /PRNewswire/ - Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ, TSX: NVCN) announced that it has...


Nov 03, 2017, 06:37 ET EYE TECH CARE erhält die Zulassung für seine Ultraschallbehandlung des grünen Stars mit EyeOP1®in China

Das preisgekrönte Medizintechnikunternehmen EYE TECH CARE hat von der China Food and Drug Administration (CFDA) die Marktzulassung für sein...


Nov 02, 2017, 22:15 ET EYE TECH CARE recibe la aprobación de la CFDA para su producto destinado al tratamiento del glaucoma EyeOP1(R)

La empresa de tecnologías médicas EYE TECH CARE ha recibido la aprobación de la Administración China de Alimentos y Medicamentos (CFDA, por sus...


Nov 02, 2017, 22:10 ET EYE TECH CARE obtient l'autorisation de la CFDA pour son produit de traitement du glaucome EyeOP1(R)

La société de technologies médicales EYE TECH CARE, qui a reçu plusieurs prix d'innovation, a reçu l'autorisation de la part de l'Administration...