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As the agency holds an advisory committee meeting today to review a proposal to slap Black Box warnings on epilepsy meds due to concerns about suicidal behavior and thoughts, some docs say the FDA may be overreacting and question whether the move wi
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In doing so, Insmed apparently becomes the first US company to demonstrate bioequivalence for a follow-on biologic. The next step is for the drugmaker to meet with the FDA in hopes of receiving a green light to proceed with a Phase III study for its
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Alice Huxley was working at Novartis when it was in the early stages of research on the blood pressure drug that’s now known as Tekturna. But Novartis didn’t want to see it through at the time, so Huxley left and started her own company,
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I will write more about this either later today or tomorrow. read more »
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