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The FDA previously granted accelerated approval under Project Orbis for Eisai’s Lenvima in combination with Keytruda for certain patients with advanced endometrial cancer. Read More
The White House Council of Economic Advisers yesterday joined in the debate over the impact of H.R. 3, a drug pricing bill currently awaiting a vote on the House floor. Read More
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) released draft advice for GMP inspectors on evaluating risk-based changes to pharmaceutical quality systems (PQSs). Read More
The Senate committee on Health, Education, Labor and Pensions voted 18-5 on Tuesday to advance Stephen Hahn’s nomination as FDA commissioner to the Senate floor. Read More
The approval makes Keytruda the first anti-PD-1 treatment option as a first-line treatment for metastatic or unresectable recurrent head and neck cancer. Read More
The board found that Pfenex had a “reasonable likelihood” of proving that its cited prior art would have rendered two of the challenged claims unpatentable. Read More