Auxilium Pharmaceuticals, a biopharmaceutical company, has obtained an approval from the US Food and Drug Administration (FDA) for Xiaflex (collagenase clostridium histolyticum) for the treatment of Peyronie's disease. The company claims ...
Tags: Peyronie's Disease Drug, Medicine
Gilead Sciences has announced that the US Food and Drug Administration (FDA) has approved Sovaldi (sofosbuvir) 400mg tablets, a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection ...
Tags: Gilead Sciences, Chronic Hepatitis
Oculus Innovative Sciences has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its new Microcyn scar management HydroGel, intended to manage old and new hypertrophic and keloid scarring resulting from burns, ...
US-based TYRX has obtained an approval from the US Food and Drug Administration (FDA) for expanded indications in marketing the AIGISRx N antibacterial envelope for use with spinal cord neuromodulators. Recently, TYRX has also obtained an ...
Cochlear, a provider of implantable hearing solutions, has obtained an approval from the US Food and Drug Administration (FDA) for the Cochlear Baha 4 attract system for use in the US. The new Baha 4 attract system is a magnetic Baha bone ...
The US Food and Drug Administration (FDA) has approved Merck's Noxafil (posaconazole) 100 mg delayed-release tablets. The tablets are a new formulation with a loading dose of 300mg (three 100mg delayed-release tablets) twice daily on the ...
US-based Boston Scientific has obtained an approval from the US Food and Drug Administration (FDA) for its Promus PREMIER everolimus-eluting platinum chromium coronary stent system. The company's next-generation durable polymer ...
CAS Medical Systems, a manufacturer of medical devices for non-invasive patient monitoring, has obtained an approval from the China Food and Drug Administration (FDA) for its FORE-SIGHT cerebral oximeter. CAS Medical Systems claims that ...
Germany-based Bayer HealthCare and US-based Onyx Pharmaceuticals have announced that the US Food and Drug Administration (FDA) has approved Nexavar (sorafenib), an oral multi-kinase inhibitor, for the treatment of patients with ...
Scanadu-a Silicon Valley-based startup seeking to commercialize a real-life version of a Star Trek tricorder- has recently raised $10.5 million in a Series A venture capital round, the company said Tuesday. The company is among the nearly ...
Tags: Scanadu, Tricorder Technology, Venture Capital Cash, Star Trek tricorder
The U.S. Food and Drug Administration approved the first adjuvanted pandemic influenza vaccine, Q-pan, to protect against H5N1 influenza, or avian flu. The vaccine, manufactured by GlaxoSmithKline, was developed in partnership with the ...
The Direxion Torqueable Microcatheter-a microcatheter for shrinking tumors or blocking aneurysms-has won FDA and CE Mark approval, Boston Scientific recently announced. The FDA granted the Direxion a 510(k) clearance because it retains ...
Tags: Boston Scientific Microcatheter, FDA Approval, Direxion a 510(k)
The RNS device receiced FDA approval via the PMA pathway. NeuroPace (Mountain View, CA) landed FDA PMA approval for its RNS Stimulator, a device that can detect and treat patients suffering from drug-resistant epilepsy. Seizures occur ...
Tags: RNS, FDA approval, PMA pathway, NeuroPace
Let's say a large medical device company has developed a new computer heart simulator that the FDA thinks is acceptable for running tests--or a new clinical trial design in a cutting-edge field. In the past, a small, early-stage company ...
Tags: Big Medtechs, public-private Medical Device Innovation Consortium, FDA
For many suffering from blindness, the perfect Christmas gift has arrived. Next month, the Argus II Retinal Prothesis System by Second Sight is slated to go on sale in the United States. The Argus II by Second Sight can restore sight for ...
Tags: Bionic Eye, blindness