Merck MRK announced that the FDA has approved both the intravenous (“IV”) and the subcutaneous (under the skin or SC) formulation of its blockbuster PD-L1 inhibitor, Keytruda (pembrolizumab), each in ...
Breakthrough personalized mRNA vaccine cuts melanoma recurrence risk by 50% when combined with Keytruda, Moderna CEO reveals ...
Merck posted a modest 2026 outlook that fell short of estimates, as it prepares for some drugs to go off patent later this ...
Armed with what CEO Robert Davis called the “broadest and widest pipeline we’ve had in years,” Merck is preparing for its ...
Please provide your email address to receive an email when new articles are posted on . The FDA approved pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph in combination with enfortumab ...
The FDA is currently reviewing Summit's PD-1/VEGF bispecific as part of a chemotherapy combo for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer.
Amgen is refusing U.S. regulators’ request to withdraw an inflammatory disease drug. Elsewhere, Pfizer battled skepticism on ...
In what is shaping up to be a back-loaded month, the FDA is set to release a slew of regulatory decisions in February, ...
Applications based on Phase 3 KEYNOTE-905 results showing the combination improved event-free survival by 60%, reduced the risk of death by 50% and increased pathologic complete response rates by 48% ...
The FDA approved adjuvant Keytruda for patients ages 12 and older with stage 2b, 2c or 3 melanoma that has been completely resected. The Food and Drug Administration (FDA) approved adjuvant Keytruda ...
TOKYO, Oct. 22, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) accepted for ...