Paid

Drugs & Targets

FDA issues Complete Response Letter on Keytruda in TNBC indication

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.
Drugs & Targets

Copiktra receives Positive CHMP Opinion for relapsed and refractory CLL and refractory FL

The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending the approval of Copiktra as monotherapy for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia after at least two prior therapies and follicular lymphoma that is refractory to at least two prior systemic therapies.