Janssen-Cilag International has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) seeking conditional approval to use the investigational drug bedaquiline (TMC207) as an oral treatment, to be used as ...
Tags: investigational drug bedaquiline, multi-drug resistant tuberculosis
The US Patent and Trademark Office (USPTO) has granted notice of allowance (NOA) to SkyePharma for a patent application 2012/0177734 of RAYOS (Prednisone) delayed-release tablets. The NOA covers the FDA-approved RAYOS, which uses the ...
Tags: SkyePharma, RAYOS delayed-release tablets, rheumatoid arthritis
Wockhardt, a high-technology intensive pharmaceutical and biotechnology company, has gained tentative FDA approval for marketing Ziprasidone, a generic anti-psychotic drug Geodon. The FDA approved generic version of 20mg, 40mg, 60mg and ...
Novartis has obtained the US Food and Drug Administration (FDA) approval for a new 13.3 mg/24 h dosage strength of its Exelon Patch (rivastigmine transdermal system), designed to treat patients with mild to moderate Alzheimer's disease. ...
Tags: Alzheimer's disease, Novartis Pharmaceuticals, Exelon Patch
Epigenomics has announced results from a comparative study between its blood-based colorectal cancer(CRC)detection test Epi proColon and fecal immunochemical testing(FIT)to demonstrate the non-inferiority of Epi proColon in detection of ...
Tags: Epigenomics, CRC, FIT, Epi proColon
Janssen Biotech and Janssen Biologics have submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) seeking approval of Simponi ...
Tags: Simponi, golimumab, active ulcerative colitis, anti-tumor necrosis factor
Quest Diagnostics has received FDA 510(k) clearance for its Simplexa C difficile Universal Direct Test on the 3M Integrated Cycler. The test, which uses a proprietary chemistry that eliminates the need for nucleic-acid extraction, is ...
Tags: Quest Diagnostics, 3M integrated cycler, Simplexa tests
MicroPhage has gained an additional FDA 510 clearance for its KeyPath MRSA/MSSA Blood Culture Test-BT. Blood test was initially cleared to diagnose and distinguish methicillin resistant and methicillin sensitive Staphylococcus aureus ...
Tags: MicroPhage, KeyPath platform, MRSA/MSSA Blood Culture Test-BT
The U.S. Food and Drug Administration (FDA) has cleared Immunetics Incorporation's BacTx rapid test used to detect bacterial contamination in platelet units. The clearance allows BacTx test use on leukocyte-reduced whole blood-derived ...
BG Medicine has filed 510(k) premarket notification for regulatory clearance of an expanded indication for its BGM Galectin-3 test with the FDA. The blood test is at present indicated for use in patients with chronic heart failure who are ...
Tags: BG Medicine, blood test, heart failure
Cardiovascular diagnostics developer BG Medicine has filed a 510(k) Premarket Notification with the US Food and Drug Administration (FDA) for regulatory clearance for the ARCHITECT Galectin-3 assay. Used with Abbott's fully automated ...
The US Food and Drug Administration (FDA) has cleared Bausch + Lomb's enVista glistening-free, single-piece hydrophobic acrylic Intraocular Lens (IOL). enVista lens, developed by Advanced Vision Science (AVS), is designed to provide ...
Tags: FDA, Bausch+Lomb's, enVista lens
Roche has gained FDA approval for the new HIV viral load test, the COBAS TaqMan HIV-1 Test, v2.0, and will launch the product in the US, later in 2012. The COBAS TaqMan HIV-1 Test, v2.0, targets two highly conserved regions of the HIV-1 ...
Sedona Labs is voluntarily recalling certain lots of iFlora Kids Multi-Probiotic dietary supplement due to a possible Salmonella contamination, according to the US Food and Drug Administration (FDA). The recall was initiated after Corn ...
Tags: dietary supplement, Salmonella contamination, fatal infections
The US Food and Drug Administration (FDA) has granted 510(k) approval to Synergetics' VersaVIT vitrectomy system for use during performing retinal surgeries. Synergetics president and CEO David Hable said, "We believe that VersaVIT is ...