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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Dec 13, 2019, 18:14 ET Amarin Receives FDA Approval of VASCEPA® (icosapent ethyl) to Reduce Cardiovascular Risk

Amarin Corporation plc (NASDAQ: AMRN) today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication and label...


Dec 13, 2019, 16:37 ET FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups

The U.S. Food and Drug Administration today approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy to reduce the risk of...


Dec 13, 2019, 16:00 ET MDA Celebrates FDA Approval of Vyondys 53 for Treatment of DMD Amenable to Exon 53 Skipping

The Muscular Dystrophy Association (MDA) today celebrated the decision by the US Food and Drug Administration (FDA) to grant accelerated marketing...


Dec 13, 2019, 14:07 ET ITF Pharma Announces FDA Approval of Supplemental New Drug Application (sNDA) for TIGLUTIK® (riluzole) Oral Suspension For The Treatment Of Amyotrophic Lateral Sclerosis (ALS) with a Percutaneous Endoscopic Gastronomy (PEG) Feeding Tube

ITF Pharma, a U.S.-based specialty pharmaceutical company and subsidiary of Italfarmaco, a privately-held European specialty pharmaceutical company,...


Dec 12, 2019, 17:44 ET FDA grants accelerated approval to first targeted treatment for rare Duchenne muscular dystrophy mutation

The U.S. Food and Drug Administration today granted accelerated approval to Vyondys 53 (golodirsen) injection to treat Duchenne muscular dystrophy...


Dec 12, 2019, 12:35 ET FDA authorizes first test to aid in newborn screening for Duchenne Muscular Dystrophy

Today, the U.S. Food and Drug Administration authorized marketing of the first test to aid in newborn screening for Duchenne Muscular Dystrophy...


Dec 12, 2019, 07:00 ET Provention Bio Reiterates Regulatory Guidance for PRV-031 (Teplizumab) Following Meeting with the FDA

Provention Bio, Inc. (Nasdaq: PRVB), a clinical stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases,...


Dec 11, 2019, 16:10 ET ImpediMed Receives FDA 510(k) Clearance of SOZO® for Expanded Indication

ImpediMed Limited (ASX.IPD), a medical software technology company that non-invasively measures, monitors and manages fluid status and tissue...


Dec 11, 2019, 08:00 ET FDA clears Cochlear's innovative new Osia® 2 hearing implant system

Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, announces today the U.S. Food and Drug Administration (FDA)...


Dec 10, 2019, 16:38 ET Correvio Announces Outcome Of FDA Advisory Committee Meeting Reviewing Brinavess™ For The Treatment Of Recent Onset Atrial Fibrillation

NASDAQ: CORV TSX: CORV VANCOUVER, Dec. 10, 2019 /PRNewswire/ - Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company...


Dec 10, 2019, 09:17 ET GIOSTAR in Process of US FDA Approval for Type 2 Diabetes Clinical Trial

Global Institute of Stem Cell Therapy and Research (GIOSTAR), the leader in regenerative technologies, is proud to announce that they are in the...


Dec 10, 2019, 08:53 ET OrthoGrid Systems Receives FDA 510(K) Clearance for New PhantomMSK Trauma Application

OrthoGrid Systems, Inc., a global medtech leader in alignment technology for orthopedic surgery, announces today that its newest application,...


Dec 10, 2019, 08:30 ET U.S. FDA Grants VistaGen Therapeutics Fast Track Designation for PH94B for Treatment of Social Anxiety Disorder

VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system ...


Dec 10, 2019, 07:37 ET TechMah Medical y LimaCorporate reciben la primera aprobación 510k para tecnología digital Smart SPACE

LimaCorporate se complace al anunciar la aprobación FDA 510K para Smart SPACE Shoulder 3D Planner & 3D Positioner. Smart SPACE es una innovadora...


Dec 10, 2019, 07:05 ET Correvio Stock Trading Halted Today; FDA Advisory Committee Meeting To Discuss Brinavess™ For Recent Onset Atrial Fibrillation

NASDAQ: CORV TSX: CORV VANCOUVER, Dec. 10, 2019 /PRNewswire/ - Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company...


Dec 10, 2019, 06:58 ET Shoulder Innovations Announces FDA 510(k) Clearance For InSet Plus™ Augmented Glenoids For Total Shoulder System

Shoulder Innovations, (SI), a leading innovator in the development of shoulder replacement systems, announced today that they have received FDA...


Dec 09, 2019, 22:34 ET TechMah Medical & LimaCorporate erhalten erste 510k-Zulassung für Smart SPACE-Digitaltechnologie

LimaCorporate freut sich, die FDA 510K-Zulassung für Smart SPACE Shoulder 3D Planner & 3D Positioner bekannt zu geben. Smart SPACE ist eine...


Dec 09, 2019, 18:51 ET TechMah Medical et LimaCorporate reçoivent la première approbation 510k pour la technologie numérique du dispositif Smart SPACE

LimaCorporate est heureuse d'annoncer l'approbation 510K de la FDA (Agence américaine des produits alimentaire et médicamenteux) pour son dispositif...


Dec 09, 2019, 12:11 ET TechMah Medical & LimaCorporate Receive First 510k Approval for Smart SPACE Digital Technology

LimaCorporate is pleased to announce the FDA 510K approval for Smart SPACE Shoulder 3D Planner & 3D Positioner. Smart SPACE is an innovative digital...


Dec 07, 2019, 07:33 ET Extended Follow-up Phase 3 Data Underscore Sustained Efficacy and Safety of IMBRUVICA® (ibrutinib) in the Treatment of Chronic Lymphocytic Leukemia (CLL)

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced results from an extended follow-up analysis of the Phase 3...


Dec 06, 2019, 14:31 ET FDA Approves Amgen's AVSOLA™ (infliximab-axxq), For The Same Indications As Remicade® (infliximab)

Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved AVSOLA™ (infliximab-axxq) for all approved...


Dec 05, 2019, 17:41 ET MolecuLight erhält 510(k)-Zulassung für sein tragbares i:X®-Gerät zur Fluoreszenz-Bildgebung in der Wundbehandlung

Neue FDA-Zulassung sieht für das Label von i:X nun den Nachweis von Bakterien und die digitale Wundvermessung vor TORONTO, 5. Dezember 2019 /CNW/ -...


Dec 05, 2019, 17:37 ET MolecuLight recibe la autorización 510(k) de la FDA para su dispositivo portátil i:X® de tratamiento de heridas

- MolecuLight recibe la autorización 510(k) de la FDA para su dispositivo portátil i:X® de imágenes por fluorescencia para el tratamiento de heridas...


Dec 05, 2019, 15:29 ET FDA approves first generics of Gilenya

The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of...


Dec 05, 2019, 06:00 ET MolecuLight obtient une autorisation FDA 510(k) pour son dispositif portable d'imagerie par fluorescence i:X® destiné au traitement des plaies

Cette nouvelle autorisation de la FDA permet d'inclure sur l'étiquette la détection des bactéries et la mesure numérique des plaies que permet l'i:X...