Keeping Track: Approvals For Polivy, Keytruda, FDA Applause For Biosimilars
The latest drug development news and highlights from our US FDA Performance Tracker.
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The US FDA issued at least 33 complete response letters to sponsors in 2019, although only one went to a biosimilar candidate.
The European Commission has approved Johnson & Johnson’s/Genmab’s CD38-targeted MAb, daratumumab, and Merck & Co’s checkpoint inhibitor, pembrolizumab, in two first-line additional indications, in multiple myeloma and head and neck cancer, respectively.