In a close but negative panel vote on the company’s acute respiratory distress syndrome treatment VERU-111 (sabizabulin), majority of US FDA advisory committee says more study should come ahead of an emergency use authorization, not as an authorization condition.
Veru Inc. may need to conduct another study of its COVID-19 therapeutic ahead of an emergency use authorization following a negative 9 November US Food and Drug Administration advisory panel.
The Pulmonary-Allergy Drugs Advisory Committee voted 8-5 that the known and potential benefits of VERU-111 (sabizabulin) do not outweigh the...
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.
