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The FDA plans to investigate how well people who have suffered hearing loss — specifically older adults — are able to understand the risk information in TV drug ads. Read More
Two institutional buyers of Gleevec want to stop its manufacturer, Novartis, from delaying generic competition of the blockbuster leukemia drug, saying a patent litigation settlement between the brandmaker and generics maker Sun Pharma was construed solely for that purpose. Read More
The FDA wants manufacturers to better control the amount of excess drug or biologic they put in injectable vials and ampules to ensure proper patient dosing. Read More
AbbVie’s hepatitis C drug combo Viekira Pak was 100 percent effective in patients with genotype 1b and liver cirrhosis without the additional use of the antiviral ribavirin, the company said Wednesday. Read More
A panel of experts in Australia is recommending that the government establish three new drug approval pathways to expedite listing on the Australian Register of Therapeutic Goods and speed novel treatments to patients. Read More
The UK’s healthcare costs regulator is asking Santen Pharmaceutical to provide more information on its Ikervis eye drops following a preliminary recommendation denying its use for the treatment of severe keratitis in adults with dry eye disease that didn’t improve with tear substitutes. Read More
The Canadian government plans to require mandatory reporting of drug shortages, in a move that will bring it in line with U.S. and European shortages policies. Read More
The amount of sodium contained as an excipient in drugs should be readily available in an understandable format on product labels and package leaflets, the European Medicines Agency says. Read More
The House Appropriations Committee is proposing $2.6 billion in new funding for the FDA, roughly $200 million less than President Barack Obama requested, but no changes to the administration’s proposed user fee levels for drugs and biologics — which total about $1.2 billion. Read More