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

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...


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,...


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 ...


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...


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...


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...


Dec 05, 2019, 06:00 ET MolecuLight Receives FDA 510(k) Clearance for its i:X® Handheld Fluorescence Imaging Device for Wound Management

New FDA Approval Extends Label to Including the i:X's Detection of Bacteria and Digital Wound Measurement TORONTO, Dec. 5, 2019 /PRNewswire/ -...


Dec 04, 2019, 06:16 ET FDA Grants Orphan Drug Designation to APR Applied Pharma Research's Investigational Drug for the Treatment of Epidermolysis Bullosa

APR Applied Pharma Research sa ("APR"), the Swiss pharma company focused in niche and rare therapeutic areas, announces that the US Food and Drug...


Dec 03, 2019, 09:00 ET Johnson & Johnson Vision Introduces TECNIS Toric II 1-Piece IOL as New Monofocal Option for Cataract Patients with Astigmatism; Launching Multi-Center, Post-Market Clinical Trials Across U.S.

Johnson & Johnson Vision*, a global leader in eye health, today announced the Food and Drug Administration (FDA) approval and U.S. launch of TECNIS...


Dec 03, 2019, 08:00 ET RightEye Vision System Receives Breakthrough Device Designation from U.S. FDA for Parkinson's Disease Test

RightEye LLC, an award-winning health technology company that uses eye-tracking technology to help diagnose and monitor health and vision issues,...


Dec 02, 2019, 10:00 ET Breckenridge Announces Final Approval of its ANDA for Rivastigmine Transdermal System (generic for Exelon® Patch)

Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug...


Dec 02, 2019, 08:00 ET Cumberland Pharmaceuticals Receives FDA Approval for RediTrex™ Product Line

Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, today announced that it has received approval from the U.S. Food...


Dec 01, 2019, 19:00 ET Innovent Biologics Announces FDA Acceptance of NDA for Pemigatinib in Patients with Previously Treated, Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusions or Rearrangements

Innovent Biologics, Inc. ("Innovent" or "the Company") (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high...


Nov 26, 2019, 07:30 ET Evofem Biosciences Resubmits New Drug Application to U.S. FDA for Amphora® for the Prevention of Pregnancy

Evofem Biosciences, Inc. (NASDAQ: EVFM), a clinical-stage biopharmaceutical company, today announced that it has resubmitted its New Drug Application ...


Nov 25, 2019, 18:00 ET FDA approves system for the delivery of ear tubes under local anesthesia to treat ear infection

The U.S. Food and Drug Administration today approved a new system for the delivery of tympanostomy tubes, commonly referred to as ear tubes, that can ...