pSivida has announced the availability of the sustained release pharmaceutical product indicated for the treatment of chronic diabetic macular edema (DME), Iluvien, in Germany. Alimera Sciences, pSivida's licensee, has reported the ...
Tags: pSivida Iluvien, Medicine
Sagent Pharmaceuticals has signed an agreement to acquire 50% interest of its joint venture (JV) partner, Chengdu Kanghong Pharmaceuticals, in the Kanghong Sagent Pharmaceutical (KSPC) JV, for $25m. KSCP will become a wholly-owned ...
Tags: Sagent Pharmaceuticals, Medicine
Think a pill that packs two cholesterol-lowering drugs in one potent package is a good idea? The Food and Drug Administration thinks so. It recently approved the combination of the popular statin drug Lipitor (atorvastatin) with another ...
Masimo (MASI) has received the US FDA 510(k) clearance for its rainbow Acoustic Monitoring sensor, RAS-125c Acoustic Respiration Cloth Sensor for monitoring acoustic respiration rate (RRa) in pediatric patients. The RAS-125c Acoustic ...
Tags: Medicine, Monitoring Sensor
The US Food and Drug Administration (FDA) has accorded its approval for a new Gibralt Occipital Spine System, developed by the US-based Exactech. The clearance is expected to allow the company to proceed with its plans to make initial ...
Tags: Spine System, Medicine
Ethicon Endo-Surgery's division Sedasys has received premarket approval (PMA) from the US Food and Drug Administration (FDA) for the first computer-assisted personalized sedation (CAPS) solution, Sedasys System. The system is used for the ...
Tags: Ethicon, Premarket Approval
Kerecis, a medical device company focused on the treatment of tissue damage with Omega3-based regenerative technologies, has announced that its recent clinical trial found no allergenic reactions to its fish-skin-composed MariGen Omega3 ...
Tags: Kerecis, Immunology Study
The US Food and Drug Administration (FDA) has granted orphan drug exclusivity to Hyperion's Ravicti (glycerol phenylbutyrate) liquid. Hyperion Therapeutics president and CEO Donald Santel said that the orphan drug exclusivity further ...
Tags: Hyperion, Ravicti Liquid
Merck, referred to as MSD outside the US and Canada, has obtained FDA approval for Liptruzet tablets as an adjunctive therapy to diet for the treatment of elevated low-density lipoprotein (LDL) cholesterol in primary or mixed hyperlipidemia ...
Tags: Merck, Liptruzet Tablets
It's not a Star Trek tricorder, but by hooking a variety of gadgets onto a smartphone you can almost get a complete physical - without the paper gown or even a visit to the doctor's office. Blood pressure? Just plug the arm cuff into the ...
Tags: Phone, Apps, Computer Products
If you've ever had trouble affording your medications and wanted to call your doctor on it, here's some encouraging news: Doctors aren't pleased about the prices either. Denouncing "profiteering" by pharmaceutical companies, more than 100 ...
Navidea Biopharmaceuticals has launched its Lymphoseek (technetium Tc 99m tilmanocept) Injection in the US. The injection is used in lymphatic mapping procedures that help in the diagnostic evaluation of potential cancer spread for ...
Tags: Navidea, Lymphoseek
The US Food and Drug Administration (FDA) has approved Raptor's Procysbi (cysteamine bitartrate) delayed release capsules for the treatment of nephropathic cystinosis in adults and children six years and older. Studies have shown that ...
Tags: Capsules, Raptor's Procysbi
Krinos Foods is voluntarily recalling its Tahini sesame paste in the US as it may be contaminated with Salmonella. The possibility for contamination was noted after the Michigan Department of Agriculture conducted routine testing on a ...
Tags: Krinos Foods, Tahini Sesame Paste
Respicardia, a US-based implantable therapies developer, has received approval from the US Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) to begin the pivotal trial of remedē System. The trial will ...
Tags: Respicardia, therapies developer