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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15 Jun, 2017, 08:00 ET Hologic Receives Expanded FDA 510(k) Clearance to Market Cynosure's SculpSure® for Non-Invasive Body Contouring (Lipolysis) of Back, Inner and Outer Thighs

Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted an expanded clearance for...


14 Jun, 2017, 09:47 ET TSO3 Expands Duodenoscope Regulatory Filing Strategy

QUEBEC CITY, QC and MYRTLE BEACH, VA, June 14, 2017 /PRNewswire/ - TSO3 Inc. (TSX: TOS), an innovator in sterilization technology for medical...


13 Jun, 2017, 14:19 ET IDFA Appreciates FDA Extension on Nutrition Facts Label Compliance

The International Dairy Foods Association appreciates the Food and Drug Administration's (FDA) announced intention to extend the...


13 Jun, 2017, 10:00 ET Interson's Latest FDA 510(k) Clearance Just Made The Future Of Ultrasound Healthcare More Accessible

Interson announced today they have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market their SiMPLi Series...


13 Jun, 2017, 09:00 ET TECHLAB® Receives FDA 510(k) Clearance To Market E. HISTOLYTICA QUIK CHEK™ To Aid Clinicians In The Diagnosis Of Amebiasis Caused By The E. Histolytica Parasite

TECHLAB,® Inc., a leading developer and manufacturer of rapid, non-invasive diagnostic tests for gastrointestinal disease, today...


08 Jun, 2017, 16:30 ET OncoSec Granted Orphan Drug Designation from the U.S. FDA for the Treatment of Unresectable Metastatic Melanoma

OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced that...


08 Jun, 2017, 09:00 ET Thornhill Medical's MOVES® SLC™ Portable Emergency Life Support System Receives 510K Clearance From The US FDA

Thornhill Medical, has received notification from the US FDA that the MOVES® SLC™ Portable Emergency Life Support System has received 510K...


08 Jun, 2017, 09:00 ET QIAGEN's QuantiFERON®-TB Gold Plus gains U.S. FDA approval

QIAGEN N.V. (NASDAQ: QGEN) (Frankfurt Prime Standard: QIA) today announced the U.S. regulatory approval of QuantiFERON®-TB Gold Plus (QFT®-Plus)...


07 Jun, 2017, 15:17 ET MedNet Solutions Set To Attend And Exhibit At DIA 2017

MedNet Solutions, an innovative cloud-based eClinical technology company that supports the entire spectrum of clinical research, is pleased to...


07 Jun, 2017, 11:30 ET Water Street's Partnership with Leading Medical Products Company Leads to FDA Approval and Commercial Launch of Clindamycin in 0.9% Sodium Chloride Injection

Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry, announced today that its development...


07 Jun, 2017, 09:00 ET Amgen And Allergan Announce FDA Advisory Committee Meeting To Review ABP 215, A Biosimilar Candidate To Bevacizumab

Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE: AGN) today announced that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug...


07 Jun, 2017, 08:00 ET FDA Approves Hologic's Genius™ 3D Mammography™ Exam as the Only Mammogram Superior for Women with Dense Breasts*

Hologic, Inc. (Nasdaq: HOLX) announced today that the Genius™ 3D Mammography™ exam is now the only mammogram that is FDA-approved as superior to...


07 Jun, 2017, 06:00 ET New FDA-Cleared Smart Heart Monitor Keeps the Cardiologist a Heartbeat Away

Eko Devices ("Eko"), the leader in mobile acoustic cardiac monitoring tools, has received FDA clearance to market its latest innovation, DUO – a...


06 Jun, 2017, 08:30 ET Ethicon Announces FDA Approval For SURGICEL® Powder Absorbable Hemostat

Uncontrolled bleeding during surgery can adversely affect patient outcomes, hospital costs and resources.1-9 Primary methods of hemostasis alone...


06 Jun, 2017, 08:00 ET PTC Therapeutics Announces FDA Advisory Committee Meeting for Ataluren for the Treatment of Nonsense Mutation Dystrophinopathy

PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the U.S. Food and Drug Administration (FDA) has notified the company of the tentative...


06 Jun, 2017, 05:30 ET OrbusNeich annonce l'autorisation de la FDA pour le lancement de ses cathéters de dilatation coronaire

Cette annonce marque l'entrée officielle de l'entreprise sur le marché des États-Unis OrbusNeich, une entreprise mondiale spécialisée dans la...


06 Jun, 2017, 05:30 ET OrbusNeich gibt FDA-Zulassung und Markteinführung von Kathetern für die Koronardilatation bekannt

Die Bekanntgabe markiert den offiziellen Eintritt des Unternehmens in den US-Markt OrbusNeich, ein weltweit agierendes Unternehmen, das auf die...


06 Jun, 2017, 05:30 ET OrbusNeich Announces FDA Clearance, Launch of Coronary Dilatation Catheters

Announcement marks company's official entry into the US market OrbusNeich, a global company specializing in the provision of life-changing...


06 Jun, 2017, 05:30 ET OrbusNeich anuncia la aprobación de la FDA y el lanzamiento de lo catéteres de dilatación coronaria

El anuncio marca la entrada oficial de la compañía dentro del mercado de Estados Unidos OrbusNeich, una compañía global especializada en el...


06 Jun, 2017, 02:00 ET QIAGEN receives U.S. FDA approval for cytomegalovirus (CMV) testing on automated QIAsymphony platform

QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it has received premarket approval from the U.S. Food and Drug...


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