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In a win for branded drugmakers, President Barack Obama signed into law a bill extending the exclusivity periods for many new drugs and biologics. The measure — H.R. 639, referred to as the “Improving Regulatory Transparency for New Medical Therapies Act” — was signed into law Nov. 25, congressional records show. Read More
The FDA is receiving criticism for again delaying a final rule on generic labeling, with some accusing the agency of putting patients at risk. Read More
The UK’s Medicines and Healthcare products Regulatory Agency has given its blessing to AstraZeneca's Tagrisso as part of the Early Access to Medicines Scheme. Read More
Given safety risks and weaker evidence in some patients, the FDA says it is questioning whether positive findings reported for Teva’s asthma drug reslizumab are enough to warrant approval. Read More
The Department of Justice has netted $96 million from the pharmaceutical industry in settlements and judgments from civil cases involving fraud and false claims against the government in the fiscal year ending Sept. 30. Read More