US FDA's Oncologic Drugs Advisory Committee will consider whether positive S-TRAC or negative ASSURE data should guide decision on expanding Sutent's renal cell carcinoma indication.
Pfizer Inc. may fight against data from a trial it helped fund to expand the renal cell carcinoma indication for Sutent (sunitinib) in the US.
The company wants to add adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following...
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The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.
Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.
The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.
US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.
The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.
US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.
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