FDA will present concerns on data collection and study conduct during advisory committee meeting on removing smoking cessation drug's boxed warning.
Pfizer Inc. will have to overcome multiple FDA questions about the conduct of its post-marketing trial assessing neuropsychiatric events related to its smoking cessation drug Chantix if it will be successful in removing the associated black box warning.
Agency reviewers identified problems with data reliability and questioned whether Pfizer payments to investigators were potentially indicative of bias in...
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.
