FDA revisits safety of Arena Pharma’s diet pill
Federal health regulators are asking tough questions about the risk of tumors and heart problems with an experimental diet pill from Arena Pharmaceuticals, which was previously rejected for similar safety concerns. The Food and Drug Administration denied approval for Arena’s lorcaserin in 2010 after scientists raised concerns about tumors that developed in animals studied with [...]
Development of a new drug in 1975 cost $100 million in today’s dollars. Now, the cost of bringing a new medicine from lab to pharmacy could exceed $1.2 billion.
Continue reading …Boston Scientific Inc. said Wednesday the Food and Drug Administration approved several new implantable heart devices the company developed. The company said the FDA approved its Incepta, Energen and Punctua devices. Incept and Punctua are implantable cardioverter defibrillators, which are used to treat rapid heartbeats. Energen is a cardiac resynchronization device, which includes an ICD [...]
Continue reading …The Food and Drug Administration has declared the blockbuster drug Avastin should no longer be used in breast cancer patients because there’s no proof it extends their lives — and it is causing dangerous side effects. Friday’s ruling was long expected, but is sure to disappoint women who say they’ve run out of other options. [...]
Continue reading …The Food and Drug Administration approved 35 new medications in fiscal year 2011, the most in a decade, with the exception of 2009. Many of the drugs are groundbreaking – including medications to treat Hepatitis C, prostate cancer, lupus and drug-resistant skin infections. Colorado Sen. Michael Bennet has advocated changes to the FDA’s approval process [...]
Continue reading …Sen. Michael Bennet is asking the Food and Drug Administration for a uniform standard that allows the agency to monitor drugs as they move through the supply chain, ensuring that all medicine is manufactured, stored and distributed safely. There are critical drug shortages in Colorado and throughout the country, and Bennet is proposing new rules [...]
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