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
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
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
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 ...
Vivus has received NDA approval for TA-1790 (avanafil), indicated for the treatment of erectile dysfunction (ED), in the US. VIvus will market the product under the brand name Stendra in the US. Mitsubishi Tanabe Pharma has ...
Tags: avanafil, erectile dysfunction, pharmaceutical product
Genmab and GlaxoSmithKline (GSK) have announced the submission of a new drug application (NDA) for Arzerra (ofatumumab) to the Japanese Ministry of Health, Labor and Welfare (MHLW). Arzerra (ofatumumab) is submitted for the approval ...
Tags: new drug application, Arzerra, chronic lymphocytic leukemia
Raptor Pharmaceutical has submitted a new drug application (NDA) to the FDA for marketing approval of Cysteamine Bitartrate delayed-release capsules (RP103), to treat nephropathic cystinosis. Raptor has appealed for priority review of ...
Tags: clinical trial, pharmaceutical product, new drug application
If you think the Nissan LEAF is the only zero-emission Nissan “vehicle” garnering attention these days, think again. There is a new model hitting the road this summer – or, more accurately, setting sail – and this ...
Tags: Nissan Design, Builds a Catamaran for World Championship Race