FDA Approvals
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Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in two doses.
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FDA Approves AstraZeneca's New Easy-to-Use, Once-weekly BYDUREON BCise Injectable Medicine for Pa...
10/23/2017
BYDUREON BCise has a unique, continuous-release microsphere delivery system designed to provide consistent therapeutic levels of the active ingredient. -
Research supporting favorable findings on the PALO ALTO Cervical Static Corpectomy Cage System to be presented at NASS 2017.
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United Therapeutics Announces FDA Approval of Third Generation Nebulizer for the Tyvaso Inhalation System
10/23/2017
United Therapeutics today announced approval by the FDA of a new inhalation device, called the TD-300/A, for use with Tyvaso (treprostinil) Inhalation Solution (Tyvaso).
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The test is intended for use with the Sofia analyzer to aid in the diagnosis of Lyme disease.
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A look at two landmark events that happened this month.
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Second CAR-T Approval Points to Exciting Times for Gene Therapy
10/20/2017
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Nexus Pharmaceuticals Receives FDA Approval for Procainamide HCL Injection, USP
10/20/2017
Nexus Pharma announced today the immediate availability in the United States of Procainamide HCL Injection, USP.
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Janssen Receives Two FDA Approvals for SIMPONI ARIA (golimumab) for the Treatment of Adults With Active Psoriatic Arthritis or Active Ankylosing Spondylitis
10/20/2017
Janssen Biotech announced today that the FDA has approved SIMPONI ARIA (golimumab), the only fully-human anti-TNF-alpha therapy administered via a 30-minute infusion, for the treatment of adults with active psoriatic arthritis or active ankylosing spondylitis (AS).
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Gilead's $12B Bet Pays Off in Two Months After the FDA Approves Kite's Revolutionary CAR-T Therapy
10/19/2017
Maybe timing is everything. On Aug. 28, 2017, Gilead acquired Kite for about $11.9B. -
Eli Lilly Looks Over Its Shoulder After Novo Nordisk Wins FDA Panel Backing for Diabetes Drug
10/19/2017
An advisory panel with the FDA gave a near unanimous support to Novo Nordisk's diabetes drug semaglutide, a long-acting GLP-1 analogue. -
BioLife Solutions Customer Kite Pharma Receives FDA Approval for Yescarta™ (Axicabtagene Ciloleucel) CAR T-Cell Therapy
10/19/2017
BioLife Solutions today announced that its customer Kite Pharma has received US FDA approval for Yescarta, the first CAR T-cell therapy for treatment of adult patients with relapsed or refractory large B-Cell lymphoma after two or more lines of systemic therapy.
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Kent's device is the next step in perfusion imaging by directly showing tissue oxygenation.
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Innovus Pharma Receives Approval From Health Canada for Vesele as a Natural Health Product
10/18/2017
Innovus Pharma announced that it has received approval from Health Canada to market its best-selling, clinically proven Vesele product as a Natural Health Product ("NHP") to help improve nitric oxide production involved in symptoms of sexual dysfunction.
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The OptiScanner 5000 is the first-of-its-kind automated bedside glucose monitoring system that provides physicians information to manage patient glucose levels in the ICU.
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Anika Announces Regulatory Approval For MONOVISC In Australia For The Treatment Of Pain Associated With Osteoarthritis Of All Synovial Joints
10/17/2017
Anika Therapeutics today announced that regulatory authorities in Australia granted approval to MONOVISC.
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The assay will help diagnose patients with RSV and/or hMPV infections.
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Second Sight Receives Approval in Germany to Begin Study to Implant and Evaluate Argus II in Better-Sighted Retinitis Pigmentosa Patients
10/17/2017
Second Sight will begin a 10-patient study to implant and evaluate the Argus II Retinal Prosthesis System in better sighted retinitis pigmentosa patients.
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New clearance for the TLL system includes indications for use with allogeneic bone graft and in additional levels of the spine.
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Janssen Announces FDA Approval Of STELARA (ustekinumab) For The Treatment Of Adolescents With Moderate To Severe Plaque Psoriasis
10/16/2017
Janssen Biotech announced today that the FDA has approved an expanded indication for STELARA (ustekinumab) for the treatment of adolescents (12 years of age or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.