Pharmaceutical industry
The US Food and Drug Administration (FDA) has granted Fast Track designation to Merck KGaA's investigational compound evofosfamide for the treatment of previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer. Evofosfamide is an investigational hypoxia-activated prodrug that is thought to be activated under severe tumor
Pharmaceutical industry
The Government of the USA, through the US Food and Drug Administration, has issued a Shortages and Discontinuations Report for Dextrose 5% Injection Bags. The report highlights the current shortage situation and provides information on the available product presentations and estimated shortage duration. The shortages are attributed to a demand
Pharmaceutical industry
The United States Government, through the Food and Drug Administration, has issued a report citing a shortage of Multi-Vitamin Infusion (MVI) products, affecting both adult and pediatric patients. The shortage stems from manufacturing delays, specifically related to the transfer of manufacturing sites. The shortage affects various presentations of MVI, including
United States. Food and Drug Administration
Pioneering a breakthrough in the treatment of chronic heart failure, the US FDA has approved Amgen's novel drug, Corlanor, providing a much-needed new option for millions of Americans and international patients suffering from this debilitating disease. As the global prevalence of heart failure increases, with over 25 million
United States. Food and Drug Administration
LILETTA, a levonorgestrel-releasing intrauterine system (IUS) approved by the U.S. Food and Drug Administration (FDA) in February 2015, has been made available in the U.S. market for use by women to prevent pregnancy for up to three years. Developed by Actavis plc, a leading global pharmaceutical company, and
United States. Food and Drug Administration
The U.S. Food and Drug Administration (FDA) has approved Eisai Inc.'s receptor tyrosine kinase inhibitor LENVIMA for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC). LENVIMA demonstrated a statistically significant progression-free survival (PFS) prolongation and response rate in patients with
United States. Food and Drug Administration
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company's New Drug Application (NDA) for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma.
Pharmaceutical industry
Mylan Inc. and its subsidiary Mylan Pharmaceuticals have been sued by Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals Inc., and Onyx Pharmaceuticals Inc. in the United States District Court in the District of Delaware. The lawsuit is connected to the filing of an Abbreviated New Drug Application (ANDA) with the U.
Pharmaceutical industry
Incyte Corporation (Nasdaq: INCY) reported its 2014 fourth-quarter and year-end financial results, including revenue from its Jakafi[R] (ruxolitinib) treatment for patients with intermediate or high-risk myelofibrosis and polycythemia vera (PV). The Company provided 2015 financial guidance and highlighted recent clinical trial results, including the FDA approval of Jakafi for
United States. Food and Drug Administration
Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company's New Drug Application (NDA) for cobimetinib in combination with Zelboraf for the treatment of people with BRAF V600 mutation-positive advanced melanoma. The
United States. Food and Drug Administration
Teva Pharmaceutical Industries and Eagle Pharmaceuticals have entered into an exclusive license agreement for Eagle's bendamustine hydrochloride (HCl) rapid infusion product for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL). Under the agreement, Teva will be responsible for all U.S. commercial activities
Pharmaceutical industry
The US Food and Drug Administration (FDA) has approved Roche's Lucentis, a vascular endothelial growth factor (VEGF) inhibitor, for the treatment of diabetic retinopathy (DR) with diabetic macular edema (DME). This approval marks a significant milestone in the treatment of DR with DME, a common diabetic eye disease
