Medical Animation Drug Approval

US FDA Ahead Of Canada, Europe In Drug-Approval Race
The U.S. Food and Drug Administration (FDA) generally approves drug therapies faster and earlier than its counterparts in Canada and Europe, according to a new study by Yale School of Medicine researchers. The study counters perceptions that the drug approval process in the United States is especially slow. Led by second-year medical student Nicholas Downing and senior author Joseph S. Ross, M...

Established Cancer Vaccine Works Better In Tandem With FDA-Approved Kidney Transplant Drug
A team from the Perelman School of Medicine and the Abramson Family Cancer Research Institute at the University of Pennsylvania found that the FDA-approved drug daclizumab improved the survival of breast cancer patients taking a cancer vaccine by 30 percent, compared to those patients not taking daclizumab. This proof-of-concept study is published this week in Science Translational Medicine...

Some Dietary Supplements May Increase Cancer Risk
Beta-carotene, selenium and folic acid - taken up to three times their recommended daily allowance, these supplements are probably harmless. But taken at much higher levels as some supplement manufacturers suggest, these three supplements have now been proven to increase the risk of developing a host of cancers...

HIV Prevention Pill Receives FDA Panel Support
On Thursday, a panel of outside experts that advises the US Food and Drug Administration (FDA) voted to support approval of the daily pill Truvada to prevent HIV in healthy people...

Drug Safety Monitoring Should Be Expanded After Approval
Pharmaceutical drugs approved by the Food and Drug Administration (FDA) but later re-called from the market - such as the antidiabetic drug Avandia and pain-reliever Vioxx - were the impetus for an Institute of Medicine committee report, recommending that the FDA take proactive steps to continue monitoring drugs' safety after initial approval and throughout their time on the market...

Levaquin Approved For Treating Plague, USA
Levaquin (levofloxacin) has been approved by the FDA for the treatment and prevention of the plague. Levofloxacin is a synthetic antibiotic of the fluoroquinolones drug class; it is currently used for the treatment of severe bacterial infection, or infections for which other antibiotics have not worked. Levaquin is produced and marketed by Janssen Pharmaceuticals Inc...

Denosumab (Xgeva) Not Approved For Metastasis Prevention
Amgen's application for expanded indications for denosumab (Xgeva) were turned down by the FDA (Food and Drug Administration) - the expanded indications were to include bone metastases prevention in patients with castration-resistant prostate cancer...

Stendra (Avanafil) For Erectile Dysfunction Approved By FDA
Stendra (avanafil), a medication for the treatment of erectile dysfunction, has been approved by the FDA (Food and Drug Administration). Erectile dysfunction refers to a man's inability to achieve a penile erection, or to maintain one. Erectile dysfunction is also known as male impotence...

Afinitor (Everolimus) Approved For Renal Angiomyolipomas By FDA
Afinitor (everolimus) has been approved by the FDA for renal angiomyolipomas (non-cancerous kidney tumors) that do not require urgent surgery in patients with TSC (tuberous sclerosis complex). Tuberous sclerosis complex is a very rare genetic condition in which non-cancerous tumors grow in the brain, kidney, skin, heart and other vital organs...

Votrient (Pazopanib) For Soft Tissue Sarcoma Approved By FDA
Votrient (pazopanib) has been approved by the FDA for the treatment of soft tissue sarcoma in patients who have already received chemotherapy. Soft tissue sarcoma is a type of cancer that starts in the fibrous tissue blood vessels, fat, muscle, or other supporting tissue in the body. The cancer develops in the mesenchymal cells...

Two Takeda Diabetes Drug Applications, FDA Asks For More Info
Takeda says it has received a complete response letter from the FDA regarding NDAs (new drug applications) for alogliptin and fixed-dose combination alogliptin and pioglitazone - both diabetes type 2 investigational therapies. Takeda says it has recently been providing the FDA (Food and Drug Administration) with postmarketing data from markets outside the USA...

Financial Conflicts Of Interest - Does Disclosure Worsen Bias?
Last month, PLoS Medicine published an article of an examination of the financial conflicts of interest of members of the American Psychiatric Association (APA), which is responsible for updating the Diagnostic and Statistical Manual of Mental Disorders (DSM)...

Monitoring Medications After Approval Has Improved Oversight, Says CDER
A more robust postmarket drug safety program has helped improve the FDA's (Food and Drug Administration) oversight of medications after they have been approved, says a report issued by CDER (Center for Drug Evaluation and Research). CDER is part of the FDA...

MS Drug Gilenya Positive Benefit-Risk Profile Following CHMP Review, Europe
According to Novartis, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has confirmed a positive benefit-risk profile for their once-a-day orally administered drug Gilenya (fingolimod). In agreement with the CHMP, the company has updated their E.U...

FDA Proposes Guidelines For Nanomaterials In Food And Cosmetics
On Friday, the US Food and Drug Administration (FDA) proposed two new draft guidelines for the evaluation and use of nanomaterials in food and cosmetics The documents are available for public comment for 90 days...