The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to Beckman Coulter's simple, non-invasive Prostate Health Index (phi) blood test. The phi test, indicated for use in men with a prostate-specific antigen (PSA) ...
Tags: phi blood test, Prostate Health Index Test, immunoassay systems
Baxter International's Gammagard liquid 10% [Immune Globulin Infusion (Human)] has got approval from the US Food and Drug Administration (FDA) as a treatment for multifocal motor neuropathy (MMN). Baxter has been given Orphan Drug ...
Tags: Gammagard liquid, FDA, MMN patients
Actavis Group has gained FDA approval to market Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules CII (Mixed Amphetamine Salts ER Capsules). The Mixed ...
Tags: FDA, Actavis Group, Amphetamine
The US Food and Drug Administration (FDA) has approved Pfizer's Lyrica (pregabalin) capsules CV for the management of neuropathic pain associated with spinal cord injury based on priority review. The FDA approval is based on two ...
Tags: FDA approval, neuropathic pain, Lyrica, clinical researh
Philippines has banned mercury-tainted infant formula from China,as a part of its effort to ensure food safety in the country. This move comes after China's product quality watchdog's recent announcement that high levels of mercury were ...
Tags: mercury-tainted, infant formula, food safety
The US Food and Drug Administration (FDA) has approved TriReme Medical's new sizes of Chocolate PTA balloon catheter. The Chocolate PTA balloon catheter, designed for the percutaneous transluminal treatment of lesions in the peripheral ...
Tags: TriReme, PTA balloon catheter, Chocolate PTA balloon catheter
Janssen Research & Development has announced that it has submitted a supplemental New Drug Application to FDA for ZYTIGA(abiraterone acetate). Janssen-Cilag International NV has also sent a type II variation to the European Medicines ...
Emmaus Medical, a subsidiary of Emmaus Life Sciences, has received European orphan medicinal product designation for Levoglutamide (L-glutamine) for the treatment of sickle cell disease. Emmaus is at present conducting a trial, at over 30 ...
Tags: sickle cell disease, clinical trial, product designation
Hospira has recalled 9 lots of cancer drugs including carboplatin, cytarabine, paclitaxel, and methotrexate packaged in vials in the US. The recall, which is based on the appearance of visible particles embedded in the glass located at ...
Tags: Recall, Cancer Drug, FDA
Watson Pharmaceuticals said Sunovion Pharmaceuticals has challenged Watson Laboratories filing of Abbreviated New Drug Application(ANDA)with the US Food and Drug Administration(FDA)seeking approval for marketing Levalbuterol Tartrate ...
Tags: Sunovion, FDA, Watson Laboratories
The US Food and Drug Administration (FDA) has cleared Siemens Healthcare's Somatom Perspective128-slice computed tomography (CT) scanner. The company said on the Somatom CT scanner, Sinogram affirmed iterative reconstruction (SAFIRE), a ...
Tags: Siemens scanner, CT scanner, scanner, computed tomography scanner
Raptor Pharmaceutical has announced FDA acceptance of new drug application (NDA) for Cysteamine Bitartrate delayed-release capsules (RP103) for the potential treatment of nephropathic cystinosis. RP103 gained standard review designation ...
Tags: nephropathic cystinosis, FDA acceptance, NDA submission
Dako, a Danish provider of cancer diagnostics solutions, has received approval from the US Food and Drug Administration to market HercepTest and HER2 FISH pharmDx Kit as companion diagnostics for pertuzumab (Perjeta) - a new Genentech ...
Tags: Dako, cancer diagnostics solutions, HercepTest, HER2 FISH
The US Food and Drug Administration (FDA) has approved Genentech's Perjeta (pertuzumab) for the treatment of HER2-positive metastatic breast cancer (mBC), in combination with Herceptin (trastuzumab) and docetaxel chemotherapy. The ...
Tags: FDA approval, breast cancer, clinical study, pharmaceutical product
The US Food and Drug Administration (FDA) has granted a conditional investigational device exemption (IDE) approval to Edwards Lifesciences' new GLX technology platform. Based on the IDE approval, the company will commence a clinical ...
Tags: FDA, IDE, Lifesciences, GLX technology