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FDA deals another blow to Fennec’s hearing loss treatment for pediatric cancer patients

FiercePharma
 2021-11-29

Cover picture for the articleThe FDA dealt another blow to Fennec Pharmaceutical’s attempt to market a drug to treat hearing loss in pediatric cancer patients. The agency issued a second Complete Response Letter targeting manufacturing issues. Following a recent preapproval inspection of its manufacturing facility, the regulatory agency noted “deficiencies have been...

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