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The House Energy and Commerce Committee passed by a voice vote Wednesday a measure that would ensure tropical disease priority review vouchers are not issued to products with regulatory approval in other countries. Read More
The FDA is spelling out the criteria for expanded access to investigational drugs in three final guidances to make the process as clear as possible. Read More
Drugmakers submitting ANDAs for products using transdermal delivery systems are expected to demonstrate that they made “reasonable efforts” to optimize the adhesive characteristics of their patches, the FDA says. Read More
A Merck unit will lose four of its five patents on its skin infection therapy Cubicin after the U.S. Supreme Court denied the drugmaker’s appeal Tuesday. Read More
A new study of oncology approvals shows that a majority of the candidates approved under accelerated review with surrogate endpoints lacked validation. Read More