The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of MSD’s ...

Overall, the results with Keytruda are very similar to that seen ... for Opdivo in second-line HCC after it became clear the EMA would not accept the data that backed its US approval.

the European Medicines Agency (EMA), endorsed its blockbuster anti-PD-1 therapy Keytruda in combination with chemotherapy for resectable non-small cell lung cancer (NSCLC). According to the ...

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved two new indications for KEYTRUDA ® (pembrolizumab), Merck ...

Keytruda (pembrolizumab) is a prescription drug that’s used to treat certain forms of cancer. Keytruda comes as an intravenous (IV) infusion (an injection into your vein given over time ...

Keytruda is used to treat advanced melanona ... These are judgement calls; the MHRA will (rightly) want to exercise due diligence. The EMA launched its adaptive licensing (AL) pilot in March ...

Among patients with early triple-negative breast cancer, treatment with Keytruda (pembrolizumab) demonstrated real-world evidence of immune-related adverse effects (irAEs) comparable with KEYNOTE-522, ...

KEYNOTE-689 trial showed significant improvement in event-free survival for stage 3 or 4A resected head and neck squamous cell carcinoma with Keytruda. Keytruda regimen included neoadjuvant therapy, ...

In particular, Keytruda for cancer represents a key blockbuster with multi-billion-dollar potential: It holds a first-mover advantage in one of the largest cancer indications of non-small cell ...

Merck, known as MSD outside of the United States and Canada, announced that the European Commission (EC) has approved two new indications for Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in ...

KEYTRUDA plus chemotherapy is the first approval in the EU for an anti-PD-1 therapy combined with chemotherapy only for patients with primary advanced or recurrent endometrial carcinoma regardless ...