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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Jun 30, 2016, 20:26 ET AbbVie's HUMIRA® (adalimumab) Receives U.S. Food and Drug Administration Approval to Treat Adults with Non-Infectious Intermediate, Posterior and Panuveitis

 AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved...


Jun 30, 2016, 09:00 ET Aratana Therapeutics Files for FDA Approval of NOCITA® (bupivacaine liposome injectable suspension)

Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on the licensing, development and commercialization of innovative...


Jun 30, 2016, 08:00 ET FDA Supports Expanded Claims for Xpert Carba-R Test for "Superbugs"

SUNNYVALE, Calif., June 30, 2016 /PRNewswire/-- Cepheid (Nasdaq: CPHD) today announced that it has received clearance from the U.S. Food and Drug...


Jun 30, 2016, 07:00 ET Concordia International Corp. Announces FDA Approval for New Photofrin® Laser

OAKVILLE, ON, June 30, 2016 /PRNewswire/ - Concordia International Corp. ("Concordia" or the "Company") (NASDAQ: CXRX) (TSX: CXR), an international...


Jun 29, 2016, 16:32 ET FDA approves implantable device that changes the shape of the cornea to correct near vision

The U.S. Food and Drug Administration today approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the clear, front surface) of...


Jun 29, 2016, 10:45 ET JustRight Surgical® first company to receive FDA clearance for use of device in pediatric patients

JustRight Surgical, LLC, the pediatric medical device company, has received FDA clearance for specific use of their 3mm JustRight Vessel Sealing...


Jun 29, 2016, 07:30 ET AbbVie Announces Fourth Breakthrough Therapy Designation Granted by the U.S. Food and Drug Administration (FDA) for Ibrutinib (IMBRUVICA®) for Chronic Graft-Versus-Host-Disease (cGVHD), a Rare Condition with Limited Treatment Options

 AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) granted a fourth...


Jun 29, 2016, 06:29 ET PharmaCielo erhält Produktionslizenz für die Verarbeitung von Cannabis-Pflanzen für medizinische und wissenschaftliche Zwecke

PharmaCielo Colombia Holdings S.A.S, eine in Rionegro ansässige hundertprozentige Tochtergesellschaft der kanadischen PharmaCielo Ltd., gab...


Jun 29, 2016, 02:51 ET PharmaCielo reçoit une licence de fabrication lui permettant de transformer des plantes de cannabis à des fins médicales et scientifiques

PharmaCielo Colombia Holdings S.A.S, basée à Rionegro, en Colombie, une filiale en propriété exclusive de la...


Jun 28, 2016, 15:20 ET PharmaCielo recibe licencia de producción y fabricación para procesar plantas de cannabis con fines medicinales y científicos

PharmaCielo Colombia Holdings S.A.S., compañía ubicada en Rionegro y subsidiaria de la canadiense PharmaCielo Ltd., anunció hoy...


Jun 28, 2016, 10:27 ET FDA approves Epclusa for treatment of chronic Hepatitis C virus infection

The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis...


Jun 28, 2016, 10:05 ET Kitov's Lead Drug KIT-302 Achieves Manufacturing Milestone Ahead of Planned NDA Filing with U.S. FDA

 Kitov Pharmaceuticals (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late-stage drug development, announced today...


Jun 28, 2016, 08:00 ET MGC Diagnostics Corporation Receives FDA 510(k) Clearance for Resmon™ PRO FULL, Forced Oscillation Technique (FOT) Device

MGC Diagnostics Corporation (NASDAQ: MGCD), a global medical technology company, today announced that the U.S. Food and Drug Administration ("FDA")...


Jun 28, 2016, 07:00 ET BioLineRx Announces Regulatory Submissions for Phase 2a Trial of BL-8040 in Combination with KEYTRUDA® (pembrolizumab) for Treatment of Pancreatic Cancer

BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing...


Jun 28, 2016, 06:54 ET Lannett Receives FDA Approval For Diazepam Oral Solution, 5 mg/5 mL

Lannett Company, Inc. (NYSE: LCI) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated...


Jun 27, 2016, 13:48 ET QT Vascular Receives FDA 510(k) Clearance For Chocolate XD™, A Novel PTCA Balloon

QT Vascular Ltd., together with its subsidiaries (the "Company" or "QT Vascular", and together with its subsidiaries, the "Group"), a global...


Jun 27, 2016, 06:30 ET Accuray Receives 510(k) FDA Clearance for the Radixact™ Image-Guided Radiation Therapy Platform and Integrated Software

 Accuray Incorporated (NASDAQ: ARAY) announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its...


Jun 27, 2016, 06:00 ET NDS receives FDA clearance for embedded wireless video receiver in Radiance Ultra displays

SAN JOSE, Calif., June 27, 2016 /PRNewswire/-- NDS today announced it has received FDA 510(k) clearance for an embedded wireless HD-video receiver...


Jun 24, 2016, 11:44 ET Mylan Launches Generic Avodart® Capsules

 Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Dutasteride Capsules, 0.5 mg, the generic version of GlaxoSmithKline's...


Jun 23, 2016, 11:30 ET Roche receives FDA clearance for its Procalcitonin (PCT) assay to help clinicians effectively assess sepsis risk and manage sepsis patients

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it has received 510(k) clearance for its Elecsys BRAHMS PCT (procalcitonin) assay as a dedicated...


Jun 23, 2016, 11:15 ET FDA Approved Longer Shelf Life for the Game Changer, Flublok® Influenza Vaccine

Protein Sciences Corporation announced today that FDA has extended the shelf life for Flublok, its game changing seasonal influenza vaccine, to 9...


Jun 23, 2016, 08:00 ET Allergan Announces FDA Approval of Supplemental New Drug Application (sNDA) for AVYCAZ® (ceftazidime and avibactam)

 Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has...


Jun 22, 2016, 08:45 ET AstaReal, Inc. Responds to Misleading BGG North America Announcement -- There Are No "FDA-Allowed Structure / Function Claims;" Calls for the Industry to Be Cautious

 AstaReal, Inc., which sells astaxanthin under the brand name, AstaReal, has issued a caution to retail manufacturers of their legal...


Jun 21, 2016, 16:43 ET Texas Cardiac Arrhythmia Institute at St. David's Medical Center First in Texas to Use Micra® Transcatheter Pacing System Post FDA Approval

The Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center recently became the first facility in Texas to use the Micra®...


Jun 21, 2016, 10:30 ET Renew® ECP is Now Indicated for Healthy Patients

 Renew Group Private Limited (RGPL) today announced that The Renew® External Counterpulsation (ECP) Therapy System received a new...