United States. Food and Drug Administration

Pharmaceutical industry

Algeta's Alpharadin Receives Fast Track Designation from FDA for Prostate Cancer Treatment

Algeta ASA, a company focused on developing novel targeted cancer therapeutics, announced that its lead product, Alpharadin (radium-223 chloride), has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of castration-resistant (hormone refractory) prostate cancer in patients with bone metastases. The company&

Pharmaceutical industry

FDA Approves Zelboraf for Metastatic Melanoma with BRAF V600E Mutation

Zelboraf (vemurafenib) has become the first and only FDA-approved personalized medicine to help people with BRAF V600E mutation-positive metastatic melanoma, a devastating disease that until now had limited approved treatment options. This approval is based on results from two clinical studies (BRIM3 and BRIM2) that demonstrated Zelboraf's effectiveness

Pharmaceutical industry

Bristol-Myers Squibb's ORENCIA Receives FDA Approval for Subcutaneous Formulation in Treating Moderate to Severe Rheumatoid Arthritis

Bristol-Myers Squibb's ORENCIA (abatacept) has been approved by the U.S. Food and Drug Administration (FDA) for a subcutaneous (SC) formulation in treating adults with moderate to severe rheumatoid arthritis (RA). This new formulation joins ORENCIA's existing intravenous (IV) infusion as a treatment option for patients

Pharmaceutical industry

FDA Approves New Formulation of Welchol for Adults with Type 2 Diabetes and High Cholesterol

The US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Welchol (colesevelam HCl) for Oral Suspension, expanding treatment options for adult patients with primary hyperlipidemia and type 2 diabetes. Welchol, first approved in 2009, is the only product approved by the FDA to improve

Pharmaceutical industry

Keryx Biopharmaceuticals Completes Patient Enrollment in Phase 3 Trial of KRX-0401 for Refractory Colorectal Cancer

Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) has completed patient enrollment in a Phase 3 registration trial of KRX-0401 (perifosine) for the treatment of refractory, advanced colorectal cancer. The trial, with over 430 randomized patients, was conducted under a Special Protocol Assessment (SPA) with the FDA and with Fast-Track Designation. The Phase

Pharmaceutical industry

Bristol-Myers Squibb Receives FDA Approval of Subcutaneous Formulation of ORENCIA for Rheumatoid Arthritis

Bristol-Myers Squibb Company has announced that the US Food and Drug Administration (FDA) has approved a subcutaneous (SC) formulation of ORENCIA (abatacept) for the treatment of adults with moderate to severe rheumatoid arthritis (RA). This approval marks a significant milestone for the company, which now offers a biologic treatment in

Pharmaceutical industry

Femta Pharmaceuticals Submits IND Application for FM101 to Treat Rheumatoid Arthritis

Femta Pharmaceuticals, a company focused on developing innovative therapeutic monoclonal antibodies, has taken a significant step forward in its research efforts by submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for FM101, a high-affinity, humanized monoclonal antibody against Interleukin-6 (IL-6), for patients

Pharmaceutical industry

FDA Requires Warning Label for Diabetes Medication Actos

The U.S. Food and Drug Administration (FDA) required added warnings on the label of the diabetes medication Actos (pioglitazone) on June 15, 2011, stating that it may increase the risk of bladder cancer when taken for more than one year. This warning came after France and Germany suspended the

Pharmaceutical industry

Strides Arcolab Secures US FDA Approval for Generic Gemcitabine Injection

Strides Arcolab, a leading manufacturer and exporter of pharmaceuticals, has received approval from the United States Food and Drug Administration (US FDA) for its generic version of the chemotherapy drug Gemzar, marketed by Eli Lilly and Company. The approval marks the company's foray into the US Oncology market

Pharmaceutical industry

FDA Advisory Committee Hears Testimony on Dapagliflozin's Risks and Ineffectiveness

A proposed diabetes treatment, dapagliflozin, developed by Bristol-Myers Squibb and AstraZeneca, has been met with criticism from Public Citizen due to its serious safety concerns and lack of clinical benefit. The drug works by blocking glucose reabsorption in the kidneys, but has been linked to increased rates of bladder and

Pharmaceutical industry

FDA Announces Most Common Flu Virus Strains for Upcoming Season

The Food and Drug Administration (FDA) has announced the three most common flu virus strains expected to be prevalent during the upcoming flu season, in collaboration with the Centers for Disease Control and Prevention (CDC) and the World Health Organization. This year's flu vaccine will include the same

Pharmaceutical industry

CytRx Corporation Receives Orphan Drug Designation from FDA for INNO-206

CytRx Corporation, a biotechnology company specializing in oncology, announced that the Office of Orphan Product Development of the U.S. Food and Drug Administration (FDA) has granted INNO-206 orphan drug designation for the treatment of patients with soft tissue sarcomas. This designation provides CytRx with exclusive rights to market INNO-206