Talon’s liposomal vincristine receives accelerated approval for refractory Ph- acute lymphoblastic leukemia, with a requirement for a confirmatory trial. The firm has a first-line trial under way for that purpose, but it wasn’t well received by the Oncologic Drugs Advisory Committee.
FDA has granted accelerated approval for Talon Therapeutics Inc. ’s Marqibo for a rare form of leukemia despite concerns raised by members of the Oncologic Drugs Advisory Committee that the confirmatory trial can be completed.
Marqibo, a liposomal form of vincristine, was approved Aug. 9 for treatment of patients with Philadelphia chromosome-negative acute lymphoblastic leukemia...
The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.
US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.
In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.
