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The UK’s National Institute for Health and Care Excellence says it will not recommend Roche’s Perjeta, raising concerns about the lack of evidence backing the drug’s long-term benefits. Read More
As the FDA makes plans for its GDUFA-mandated fiscal 2017 Regulatory Science Plan, industry trade groups are pushing the agency to spend more time communicating its intentions. Read More
The U.S. Senate and House passed spending bills to fight the Zika virus within 24 hours of each other. The distinct measures both include HHS funding for vaccines, therapies and diagnostic tests. Read More
The European Medicines Agency recommendations for drug approvals saw a steady uptick in 2015, even as the number of new active substances fell slightly. Read More
The Secretary’s Advisory Committee on Human Research Protections is recommending that the FDA revise its informed consent waivers for cluster randomized trials to mirror HHS rules. Read More
The Senate Appropriations Committee unanimously approved a fiscal 2017 funding bill Thursday that would provide the FDA with $4.78 billion in total funding, around $100 million above the current funding level. Read More
GlaxoSmithKline is appealing a $54 million fine from the UK’s Competitions and Market Authority over pay-for-delay allegations, contending the company’s conduct was “objectively justified.” Read More