US FDA's ODAC members decide potential "life-changing" benefits of Daiichi's proposed rare cancer therapy outweigh liver risks.
The potentially transformative effect of Daiichi Sankyo Co. Ltd.'s proposed rare cancer treatment pexidartinib trumped concerns about liver toxicity and the monitoring that may be required in advisory committee members' minds.
The US Food and Drug Administration's Oncologic Drugs Advisory Committee voted 12-3 that the benefits of pexidartinib outweighed the risks...
Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.
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.
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.
