Roche has submitted TnT-hs assay's 510(k) application to the US Food and Drug Administration (FDA) for use on its cobas immunoassay and Elecsys analyzers. The TnT-hs is an electrochemiluminescence immunoassay designed for in-vitro ...
Tags: FDA, Roche, TnT-hs assay, analyzers
NinePoint Medical, a developer of real-time in vivo pathology devices, has obtained CE mark approval for its NvisionVLE Imaging system. The NvisionVLE Imaging system facilitates physicians and pathologists to view real-time volumetric ...
Tags: NinePoint Medical, NvisionVLE Imaging system, optical imaging
Lupin Pharmaceuticals has received FDA approval for Suprax (Cefixime) capsules 400mg and will initiate the shipment of the product shortly. The approval will expand Lupin's range of Suprax dosage forms available to treat the approved ...
The US Food and Drug Administration (FDA) has cleared Arteriocyte Medical Systems' 50cc volume of Anticoagulant Citrate Dextrose Solution, USP (ACD-A) for use with its Magellan Platelet Separation system. The Magellan system utilizes ...
Tags: FDA, Anticoagulant Citrate Dextrose Solution, clinical technology
Astellas Pharma has gained FDA approval for Myrbetriq (mirabegron) extended-release tablets for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. Myrbetriq is a once ...
Tags: FDA approval, pharmaceutical product, oral OAB treatment
Ligand Pharmaceuticals partner GlaxoSmithKline has submitted regulatory applications in the US and European Union for the use of eltrombopag (Promacta/Revolade) to increase platelet counts in patients with hepatitis C. A supplemental ...
Cornerstone Therapeutics, a specialty pharmaceutical company, has received FDA approval for its abbreviated new drug application (ANDA) for a generic Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release suspension ...
Tags: FDA approval, pharmaceutical product, generic antitussive product
Exelixis has completed the submission of new drug application (NDA) for cabozantinib as a treatment for progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC) patients, with the FDA. Cabozantinib is ...
Tags: submission of new drug application, FDA, pharmaceutical product
Cipher Pharmaceuticals, a specialty pharmaceutical company, has received FDA approval for Absorica for the treatment of severe recalcitrant nodular acne. The company expects to launch its patented brand formulation of the acne ...
The US Food and Drug Administration (FDA) has granted 510(k) approval to Medigus's SRS endoscopic system. The approval was based on a multi-center clinical trial which met a criteria of safety and efficacy in five countries and three ...
Tags: SRS endoscopic system, endoscopic system, SRS endoscope, the SRS system
Auxilium Pharmaceuticals and FCB have filed a patent infringement lawsuit, related to Testim 1% testosterone gel, against Watson Laboratories, Watson Pharmaceuticals, and Watson Pharma. The lawsuit was filed in the US District Court ...
Tags: patent infringement lawsuit, Watson, generic product, FDA
Medivation and Astellas Pharma have announced the submission of new drug application (NDA) for enzalutamide (formerly MDV3100) to the FDA. The enzalutamide has been studied in patients with castration-resistant prostate cancer who ...
Tags: enzalutamide, new drug application, pharmaceutical product
Watson Pharmaceuticals has confirmed the filing of ANDA with FDA by Watson Laboratories seeking approval to market Norethindrone Acetate/Ethinyl Estradiol and Ethinyl Estradiol and Ferrous Fumarate Tablets, 1mg/0.01mg and 0.01mg and 75mg. ...
Tags: pharmaceutical product, pregnancy prevention drug, FDA
Digestive Care (DCI) has gained FDA approval for its new drug application (NDA) for Pertzye, a pancreatic enzyme product containing bicarbonate-buffered enteric-coated microspheres. Pertzye is indicated for the treatment of Exocrine ...
Emergent BioSolutions has received FDA approval for its supplemental Biologics License Application (sBLA) to change the administration schedule of BioThrax to a three-dose primary series of intramuscular injections at zero, one, and six ...
Tags: Medicine, Emergent BioSolutions, Anthrax Vaccine Adsorbed