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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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 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, 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, 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...


Feb 17, 2017, 08:42 ET Perrigo Announces FDA Final Approval For Hydrocodone Bitartrate And Homatropine Methylbromide Oral Solution

Perrigo Company plc (NYSE, TASE: PRGO) today announced it has received final approval from the U.S. Food and Drug Administration for hydrocodone...


Feb 16, 2017, 08:08 ET U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Pegfilgrastim for Review

Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has...


Feb 16, 2017, 08:00 ET FDA Expands Approval of SPIRIVA® RESPIMAT® (tiotropium bromide) Inhalation Spray for Maintenance Treatment of Asthma in Children

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved SPIRIVA RESPIMAT for the...


Feb 16, 2017, 07:00 ET Valeant Receives FDA Approval Of SILIQ™ (Brodalumab) For Moderate-To-Severe Plaque Psoriasis

Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) (“Valeant” or the “Company”) today announced that the...


Feb 15, 2017, 17:56 ET FDA approves new psoriasis drug

The U.S. Food and Drug Administration today approved Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. Siliq is...


Feb 15, 2017, 10:42 ET FDA Approval Granted for BIOTRONIK's Ultra-Thin PRO-Kinetic Energy Cobalt Chromium Coronary Stent System

PRO-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System from BIOTRONIK gained FDA approval utilizing results from the BIOHELIX-I clinical...


Feb 15, 2017, 08:00 ET The FDA has Approved Tirosint-SOL, Levothyroxine in Liquid Solution for the American Market, IBSA Patent

IBSA announced today that the US Food and Drug Administration (FDA) has approved Tirosint-SOL (levothyroxine sodium oral solution), a liquid...


Feb 15, 2017, 07:00 ET Cepheid Announces FDA Clearance Of Xpert® Xpress Flu And Xpert Xpress Flu/RSV

Cepheid today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Xpert® Xpress Flu and Xpert...


Feb 15, 2017, 06:00 ET L'FDA ha Approvato per il Mercato Americano Tirosint-SOL, Levotiroxina, Formulazione Liquida, Brevetto IBSA

Studi Clinici hanno Dimostrato che Tirosint-SOL è in Grado di Superare Alcuni Limiti Delle Compresse di Levotiroxina IBSA annuncia oggi che US...


Feb 15, 2017, 02:00 ET La FDA a approuvé Tirosint-SOL (lévothyroxine en solution liquide) pour le marché américain, avec un brevet IBSA

Des études cliniques ont démontré que Tirosint-SOL peut vaincre certaines des limites inhérentes aux comprimés de lévothyroxine IBSA a...


Feb 15, 2017, 02:00 ET La FDA ha aprobado Tirosint-SOL, levotiroxina en solución líquida para el mercado americano, patente IBSA

Estudios clínicos han demostrado que Tirosint-sol podría superar algunas de las limitaciones de las tabletas de levotiroxina IBSA anunció...


Feb 15, 2017, 02:00 ET FDA genehmigt Tirosint-SOL, Levothyroxin in flüssiger Lösung, für den amerikanischen Markt - Patent von IBSA

Klinische Studien haben gezeigt, dass Tirosint-SOL einige der Einschränkungen von Levothyroxin-Tabletten überwinden IBSA hat heute...