St. Jude Medical, a US-based medical technology company, has received the U.S. Food and Drug Administration (FDA) approval for its new MediGuide Enabled Ablation Catheters designed to treat specific irregular heartbeats. Utah Valley ...
ViiV Healthcare, HIV company established by GlaxoSmithKline and Pfizer, has announced the FDA approval of an integrase inhibitor, Tivicay (dolutegravir) 50mg tablets, for the treatment of HIV-1. Tivicay is indicated for use in combination ...
Tags: Viiv Healthcare, HIV-1
Quantel Medical has received the U.S. Food and Drug Administration (FDA) approval for its selective laser trabeculoplasty (SLT) glaucoma laser for clinical use, called Solutis. Solutis is a 532nm SLT laser designed for primary open angle ...
Tags: Quantel Medical, Glaucoma Laser
The US Food and Drug Administration (FDA) has approved Alere's pre-market application (PMA) for the commercialization of Alere Determine HIV 1/2 Ag/Ab Combo in the country. The FDA approval allows the marketing of Alere Determine HIV 1/2 ...
Tags: Alere Determine, Medicine
LDR has received a letter of approval from the US Food and Drug Administration (FDA) for commercial sale and distribution of its Mobi-C Cervical Disc (Mobi-C), for one-level indications in the US. The Mobi-C is designed for cervical disc ...
Tags: Mobi-C Cervical Disc
CorMatrix Cardiovascular, a US-based medical device manufacturer, has received three patents from the US Patent and Trademark Office for its biomaterial heart valve that is made from biomaterial called extracellular matrix (ECM). The ...
Tags: Matrix Heart Valve, CorMatrix
Perrigo Company has received final FDA approval for abbreviated new drug application for generic equivalent to cutivate lotion, 0.05% and begins immediate shipment of the product. Cutivate Lotion 0.05% (fluticasone propionate lotion, ...
The US FDA Nonprescription Drugs Advisory Committee (NDAC) has recommended approval of Sanofi's Nasacort AQ nasal spray (triamcinolone acetonide) for over-the-counter use in the country. Nasacort AQ Nasal Spray is indicated to treat the ...
Tags: Nasacort AQ Nasal Spray, Medicine
Oral drug delivery systems developer Oramed Pharmaceuticals has submitted a pre-Investigational New Drug (pre-IND) seeking approval from the US Food and Drug Administration (FDA) to commence a trial on its orally ingestible exenatide ...
US-based BioFire Diagnostics has begun clinical and analytical studies to evaluate its FilmArray Gastrointestinal (GI) Panel. This clinical study is being conducted at several hospital-based clinical laboratories in the US and is funded ...
The European Commission has granted orphan drug designation to BrainStorm Cell Therapeutics’ stem cell therapy NurOwn to treat Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's Disease. NurOwn consists of autologous ...
Tags: Orphan Drug, Medicine
Hologic's Aptima HPV assay has received clearance from the US Food and Drug Administration (FDA) for use on its fully-automated Panther system, enabling laboratories to run multiple tests from a single specimen. A nucleic acid amplified ...
Tags: Panther System, Aptima HPV Assay
Mylan Pharmaceuticals and Orion have entered into a settlement and license agreement, which dismisses the parties pending litigation related to Mylan's filing of an Abbreviated New Drug Application (ANDA) with the US FDA for the generic ...
Tags: Mylan, Orion, Generic Version
Hologic, a developer of medical imaging systems and surgical products, has received approval for its Aptima HPV assay for use on its fully-automated Panther system from the US Food and Drug Administration (FDA). The assay is a nucleic ...
Tags: Aptima HPV, Medicine
The US FDA has approved Janssen Biotech's Simponi ARIA (golimumab) for infusion to treat moderately to severely active rheumatoid arthritis (RA). Simponi ARIA is the only fully-human anti-tumor necrosis factor (TNF)-alpha infusible ...