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

Feb 28, 2017, 07:00 ET FDA Accepts the Biologics License Application for Avelumab for the Treatment of Metastatic Urothelial Carcinoma for Priority Review

- Second Biologics License Application accepted by the FDA for avelumab - Prognosis for urothelial carcinoma is currently poor,...


Feb 27, 2017, 11:30 ET ViewRay Receives FDA 510(k) Clearance for MRIdian Linac

Announces Fourth Quarter and Full Year 2016 Financial Highlights, including Record Revenue and $133.2 million in Backlog ViewRay, Inc. (Nasdaq:...


Feb 27, 2017, 08:30 ET RegeneRx Licensee Receives FDA Permission to Conduct a Phase 3 Trial of RGN-137 for Epidermolysis Bullosa in U.S.

RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue...


Feb 27, 2017, 08:00 ET Bracco Diagnostics Inc. Receives U.S. FDA Approval for VARIBAR® PUDDING (barium sulfate) oral paste for Fluoroscopy

Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announced...


Feb 27, 2017, 08:00 ET Philips receives FDA 510(k) clearance to market its ElastQ Imaging shear wave elastography for non-invasive assessment of tissue stiffness of the liver

Royal Philips (NYSE:PHG AEX: PHIA), a global leader in health technology, today announced 510(k) clearance from the U.S. Food and Drug...


Feb 27, 2017, 06:01 ET OncoSec Granted FDA Fast Track Designation for ImmunoPulse® IL-12 for the Treatment of Metastatic Melanoma Following Progression on Pembrolizumab or Nivolumab

OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, received Fast Track...


Feb 27, 2017, 01:30 ET Bausch + Lomb And Nicox Resubmit US New Drug Application For Novel Glaucoma Candidate Latanoprostene Bunod

Valeant Pharmaceuticals International, Inc.'s (NYSE: VRX and TSX: VRX) wholly owned subsidiary, Bausch + Lomb, and Nicox S.A. (NYSE Euronext Paris:...


Feb 23, 2017, 17:30 ET FDA clears test to help manage antibiotic treatment for lower respiratory tract infections and sepsis

The U.S. Food and Drug Administration today cleared the expanded use of the Vidas Brahms PCT Assay to help health care providers determine if...


Feb 23, 2017, 09:00 ET U.S. FDA Approves Increase in Number of Clinical Sites for E-QURE’s Pivotal Trial of BST Device for the Treatment of Chronic Wound Care

Could potentially shorten study period by more than six months E-QURE Corp. (OTCQB: EQUR), a leader in medical devices for the treatment of...


Feb 23, 2017, 08:00 ET Tocagen Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Toca 511 & Toca FC in Recurrent High Grade Glioma

Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, today announced the U.S. Food and Drug Administration (FDA) has granted Toca...


Feb 23, 2017, 07:30 ET Novartis drug Zykadia receives FDA Priority Review for first-line use in patients with ALK+ metastatic NSCLC

Novartis today announced that the US Food and Drug Administration (FDA) accepted the Company's supplemental New Drug Application (sNDA) for filing,...


Feb 23, 2017, 07:00 ET Resverlogix Reports Positive FDA Type B Meeting on Design Issues Relating to a Proposed Phase 2a Kidney Dialysis Trial

Protocol comments and recommendations incorporated CALGARY, Feb. 23, 2017 /PRNewswire/ - Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:...


Feb 23, 2017, 07:00 ET BioLight's TeaRx Multi-Parameter Diagnostic Assays to be Used in Dry Eye Syndrome Drug Trial

BioLight Life Sciences Ltd. (TASE: BOLT) ("BioLight"), an emerging global ophthalmic company focused on the discovery, development and...


Feb 23, 2017, 00:01 ET First-Ever Device for Fast and Virtually Painless Blood Draw Receives FDA Clearance

Seventh Sense Biosystems, Inc. (7SBio) announced today that a new blood collection device called TAP has received U.S. Food and Drug Administration...


Feb 22, 2017, 08:00 ET Revolutionary Diagnostic SeptiCyte™ LAB Cleared By FDA for Suspected Sepsis Patients

Immunexpress, Inc., a molecular diagnostic company committed to improving outcomes for suspected sepsis patients and healthcare providers, today...


Feb 22, 2017, 08:00 ET LifeBond's Multi-Center International Pivotal Study of the LifeSeal Surgical Sealant for GI Resections is Enrolling Patients in the US and Europe

LifeBond, a leader in the development of bio-surgical medical devices for tissue repair, announced today that 20 leading medical centers in the...


Feb 22, 2017, 07:58 ET In Vitro Diagnostics News of Note: Kalorama Information - February 2017

Kalorama Information presents five news stories related to in vitro diagnostics that represent significant developments. Among the top news...


Feb 22, 2017, 06:59 ET BD Veritor™ System Meets FDA's New Performance Requirements for Rapid Influenza Antigen Detection Tests

Effective Feb. 13, 2017, the Food and Drug Administration (FDA) has reclassified antigen based rapid influenza virus antigen detection systems...


Feb 22, 2017, 06:54 ET Lannett Provides Further Update On Methylphenidate ER Tablets

Lannett Company, Inc. (NYSE: LCI) today announced that it was notified by U.S. Food and Drug Administration (FDA) late yesterday afternoon that FDA...


Feb 20, 2017, 07:30 ET Intensix Announces Positive Study Results of its Predictive Analytics Platform in the ICU Relating to Sepsis

Intensix, developer of a real-time predictive analytics platform for early detection of patient deterioration in the ICU and high acuity...