• Heron Therapeutics receives complete response letter from FDA for HTX-011

    11 days ago - By Healio

    Heron Therapeutics Inc. has received a complete response letter from the FDA for HTX-011 for the management of postoperative pain, according to a company press release.
    The FDA was unable to approve the new drug application and issued the complete response letter on the need for additional chemistry manufacturing and control and non-clinical information. The FDA found no clinical safety or efficacy issues and there is no requirement for further clinical studies or data analyses, according to the release.
    “We are committed to resolving the non-clinical issues outlined in the CRL [complete
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