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FDA Advisory Committees

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Purdue's Butrans: US FDA Panel To Consider Pediatric Labeling, But Not A New Indication

Purdue says it conducted a trial required under the Pediatric Research Equity Act but is not seeking a formal indication and will not promote the opioid for pediatric populations. Two advisory committees will discuss the trial results and whether they support additional labeling for the buprenorphine transdermal product Sept. 13.

Advisory Committees Pediatrics

Kite’s Axi-Cel CAR-T: No Adcomm, No Problem

Next CAR-T in line at US FDA, Kite’s axicabtagene ciloleucel, looks headed toward an early approval with the agency confirming no panel will be scheduled, according to the firm. But the company and FDA may have benefited from an advisory committee review.

Advisory Committees Drug Review

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

US FDA Panel Weighs Design Of A Pre-approval Safety Study For Janssen's Sirukumab

IL-6 inhibitor should be compared to another biologic to exclude a multi-fold increase in the risk of death, advisers say; FDA assures the panel's industry representative it is not considering an across-the-board requirement for large safety studies of rheumatoid arthritis treatments.

Advisory Committees Biologics

Heplisav Postmarketing Worries Push PDUFA Date Back; FDA Seeks More Details

Dynavax's final pivotal trial for hepatitis B candidate was missing data from 150 patients, making its causality of myocardial infarctions unclear; the question now is whether the postmarketing trial can answer the question.

Advisory Committees Vaccines

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review
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