Will FDA approve a new antibiotic despite 'significant' safety issues?
In a dramatic squeaker, a regulatory panel of experts last Friday narrowly recommended that an antibiotic from Cempra, an upstart developer, should be approved for use. But the 7 to 6 vote suggested an acknowledgement of what one Wall Street analyst calls a “screaming unmet” need for new treatments that outweigh the sort of safety concerns surrounding the product.
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