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The FDA is renewing the call for nominations for the list the agency is building of active drug substances that can be used to compound drug products, saying many of the responses to its December effort to build the list were inadequate. Read More
Manufacturers of generic versions of cholesterol drugs Darvocet and Darvon can’t be held liable for not changing their labels to note safety warnings without prior FDA approval, an appeals court has ruled, further entrenching generic drugmakers’ protections from failure-to-warn and other lawsuits. Read More
Over the next five years the FDA plans to increasingly coordinate its inspections and enforcement activities with its international counterparts. Read More
A European Medicines Agency committee has clarified what kinds of drugs may be classified as advanced-therapy medicinal products (ATMPs), including the criteria for classifying cells and tissues as "engineered." Read More
In a reversal of its 2010 guidance, the UK's cost-benefit watchdog now recommends coverage of Novartis' cancer drug Glivec in some patients following surgery for gastro-intestinal stromal tumours (GIST).
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The U.S. Patent and Trademark Office's recently established patent review board has received what appears to be its first challenge to a drug patent covering a business practice rather than a drug's attributes. Read More
Allergan got bad and good news recently from the FDA, with the agency rejecting for a second time the company's migraine treatment Semprana due to manufacturing issues but approving a new indication for its eye treatment Ozurdex. Read More
Drugmakers with products on the market in Europe have less than two months before they must start paying thousands of dollars in new fees to fund EU pharmacovigilance activities. Read More
Warning is unrelated to FDA’s investigation into risk of heart attack, stroke and death linked to blood clots in arteries in testosterone patients. Read More