Merck’s Keytruda (pembrolizumab) received a rejection from the U.S. Food and Drug Administration for each of six supplemental Biologics License Applications to update the dosing frequency of the checkpoint inhibitor to include every-six-weeks administration.

Humira’s dominance continues as the world’s top-selling prescription product as the biologic therapy is the first drug to exceed $20 billion in annual global sales.

Merck received FDA approval for new indications for the PARP inhibitor Lynparza – which is jointly developed and commercialized by AstraZeneca – and the checkpoint inhibitor Keytruda.

Checkmate Pharmaceuticals announced a clinical trial collaboration and supply agreement with the alliance between Merck KGaA and Pfizer Inc. to evaluate the TLR9 agonist CMP-001 in combination with the human anti-PD-L1 antibodyavelumab.

Merck KGaA and Pfizer Inc. announced that the U.S. FDA granted Breakthrough Therapy Designation for avelumab in combination with Inlyta (axitinib) treatment-naïve patients with advanced renal cell carcinoma.

European regulators granted market approval for Merck KGaA and Pfizer’s immuno-oncology drug Bavencio to treat a rare and aggressive type of skin cancer called Merkel cell carcinoma.

U.S. health regulators granted accelerated approval for Pfizer Inc.’s immuno-oncology drug Bavencio to treat advanced bladder cancer, marking the second approval in less than two months for the treatment developed along with Germany’s Merck KGaA.

The U.S. FDA approved Bavencio (avelumab) Injection 20 mg/mL for ttreating adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma.

Pfizer Inc and Germany’s Merck KGaA started the second late-stage drug trial of its avelumab drug against lung cancer, targeting a slice of the growing but crowded cancer immunotherapy field.   Avelumab, designed to help the immune system detect and fight tumors, will be tested on newly diagnosed lung-cancer cases in the third and last […]