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 06, 2017, 09:00 ET Kindred Biosciences Receives Early Approval of Effectiveness Technical Section from FDA for Mirataz™ New Animal Drug Application

Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced it has...


Feb 03, 2017, 17:41 ET Intarcia Announces FDA Filing Acceptance of New Drug Application (NDA) for ITCA 650 for the Treatment of Type 2 Diabetes

Intarcia Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for active review its New Drug...


Feb 02, 2017, 08:00 ET U.S. FDA Grants Abbott the First Commercial Authorization for a Molecular Test to Detect Zika Virus Using Whole Blood

Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has authorized its molecular test, the Abbott RealTime ZIKA...


Feb 02, 2017, 08:00 ET U.S. FDA Grants Priority Review to AbbVie for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)

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


Feb 01, 2017, 16:30 ET Zimmer Biomet Announces FDA Approval of Expanded 26-week Efficacy Claim for Gel-One® Cross-Linked Hyaluronate for Treatment of Pain Associated with Knee Osteoarthritis

Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that the U.S. Food and Drug...


Feb 01, 2017, 09:15 ET New Studies on Hazardous Drug Delivery Confirm Equashield to be Truly Closed System, as Defined by NIOSH

Equashield, a leading provider of Closed System Transfer Devices (CSTDs) for the safe and simple handling of hazardous drugs, today announced the...


Feb 01, 2017, 08:38 ET Kitov Granted Notice of Allowance from U.S. Patent & Trademark Office for KIT-302

Patent Further Strengthens Company's IP position ahead of Planned New Drug Application to be Submitted to FDA Kitov Pharmaceuticals Holdings Ltd....


Feb 01, 2017, 08:00 ET Abbott Announces U.S. Approval for its Assurity MRI™ Pacemaker, the World's Smallest, Longest-Lasting Wireless MRI-Compatible Pacemaker

Abbott (NYSE: ABT) today announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for both the...


Feb 01, 2017, 08:00 ET Sanofi's Xyzal® Allergy 24HR Approved for Over-the-Counter Use in the United States

Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved Xyzal® Allergy 24HR as an over-the-counter (OTC) treatment for the...


Feb 01, 2017, 08:00 ET Audentes Therapeutics Announces FDA Clearance of Investigational New Drug Application for AT342 to Treat Crigler-Najjar Syndrome

Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing gene therapy products for patients...


Jan 31, 2017, 14:09 ET FDA Grants New Clearance for Brain Surgery Technology

The U.S. Food and Drug Administration (FDA) in less than a 15-month period has granted a new and updated 510(k) clearance for two patented...


Jan 30, 2017, 17:26 ET Endo Announces U.S. FDA Approval of Ephedrine Sulfate Injection, USP

Endo International plc (NASDAQ / TSX: ENDP) announced today that one of its operating companies, Par Pharmaceutical has received final approval...


Jan 30, 2017, 07:59 ET FDA Approves Allergan's sNDA for AVYCAZ® (ceftazidime and avibactam) to include new Phase III data in Patients with Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis

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


Jan 30, 2017, 07:00 ET Compugen Fourth Quarter and Yearend 2016 Conference Call Scheduled for Wednesday, February 15, 2017 at 10:00 AM EST

Compugen Ltd. (NASDAQ: CGEN), a leading predictive drug discovery company, today announced that the Company will host a conference call on...


Jan 27, 2017, 07:00 ET OWC Pharmaceutical Research Corp Announces the Nominations of Ms. Miriam Sani, MSc Eng., to its Advisory Board

OWC Pharmaceutical Research Corp. (OTCQB: OWCP), ("OWC" or the "Company"), an Israeli-based developer of cannabinoid-based therapies targeting a...


Jan 26, 2017, 08:03 ET Gramercy Extremity Orthopedics Receives FDA 510(k) Clearance for GEO™ Bone Screw System

Gramercy Extremity Orthopedics (GEO) today announced it received the U.S. Food and Drug Administration's (FDA) 510(k) clearance for the GEO™ Bone...


Jan 26, 2017, 07:01 ET U.S. Food and Drug Administration Approves 72 mcg Dose of LINZESS® (linaclotide) for Adults with Chronic Idiopathic Constipation

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Allergan plc (NYSE: AGN) announced today that the U.S. Food and Drug Administration (FDA) has...


Jan 25, 2017, 08:34 ET NARCAN® (naloxone HCl) Nasal Spray 2mg Approved by U.S. Food and Drug Administration (FDA)

Today, the U.S. Food and Drug Administration (FDA) approved NARCAN® Nasal Spray as a 2mg formulation for the emergency treatment of known or...


Jan 25, 2017, 08:00 ET AbbVie Initiates Phase 2 Clinical Trial Programs for ABBV-8E12, an Investigational Anti-Tau Antibody, in Early Alzheimer's Disease and Progressive Supranuclear Palsy

AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced the start of two Phase 2 clinical trial programs to evaluate ABBV-8E12, an...


Jan 24, 2017, 17:15 ET Center For Sight Offers Las Vegas Presbyopia Patients Newest FDA-approved Corneal Inlay Surgery for Reduced Dependence on Reading Glasses

Las Vegas ophthalmology practice, Center For Sight, announced today its introduction of the Raindrop Near Vision Inlay, the second FDA-approved...


Jan 24, 2017, 16:10 ET Bio-Techne Congratulates Astute Medical on Clinical Trial Results

In a major study released this weekend from the University Hospital Muenster, Germany1...


Jan 24, 2017, 10:15 ET Mezzion has filed suit against Dr. Reddy's

Mezzion has filed a suit for damages against Dr. Reddy's in New Jersey State court alleging that Dr. Reddy's committed fraud relating to Dr....


Jan 24, 2017, 08:40 ET Perrigo Announces FDA Approval Of Its First-To-File AB Rated Generic Version Of Topicort® Spray, 0.25%

Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received U.S. Food and Drug Administration approval for its first-to-file Abbreviated...


Jan 24, 2017, 08:30 ET FDA Accepts BeyondSpring IND Application for Plinabulin for the Prevention of Chemotherapy-Induced Neutropenia

BeyondSpring Pharmaceuticals, a global clinical stage biopharmaceutical company focused on the development of innovative immuno-oncology cancer...


Jan 24, 2017, 06:00 ET Prescient Surgical Wins FDA De Novo Clearance for CleanCision System

The FDA's Center for Devices & Radiological health granted de novo clearance for Prescient Surgical's CleanCision Wound Retraction and...