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will be game over for these products until they can successfully traverse the regulatory process," Gottlieb warned. The FDA has the authority to block e-cigarette sales and force makers to go through the formal

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brought on by cancer treatment. Biosimilars are intended to be lower cost, high-quality treatment options that have the potential to alleviate such burden. We sincerely hope our trastuzumab biosimilar will do exactly that,” said Sang-Jin Pak, Senior Vice President

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