FDA has issued a Complete Response Letter regarding Merck’s supplemental Biologics License Application seeking approval for Keytruda, Merck’s company’s anti-PD-1 therapy, for the treatment of patients with high-risk early-stage triple-negative breast cancer, in combination with chemotherapy as neoadjuvant treatment, then continuing as a single agent as adjuvant (post-operative) treatment after surgery.
The Biden administration has left NIH in a weakened state, intensifying politicization of science on Capitol Hill and eroding the bipartisan support the government’s premier biomedical research agency has traditionally enjoyed.
