Topic: FDA advisory committee
Doctors fear that the only drug approved to prevent preterm birth will no longer be available after an FDA advisory committees vote in October.
Tuesday, the FDA’s panel of experts voted 7-5 to approve Lynparza in tough-to-treat pancreatic cancer.
Less than a month after its initial FDA approval, Celgene's Reblozyl will answer to an FDA committee for its hopes in myelodyplastic syndromes (MDS).
It's taken years for Amarin's Vascepa to prove itself as a game-changing treatment for CV disease. An FDA committee may have just punched its pass.
Eli Lilly and Boehringer Ingelheim failed to persuade an FDA expert panel that their SGLT2 med, Jardiance, could be repurposed for Type 1 diabetes.
Days before Amarin faces a pivotal FDA vote on its Vascepa expansion, advisors are set to scrutinize the placebo used in its pivotal outcomes trial.
With an FDA panel meeting looming, Amarin has pushed back plans to double its Vascepa sales team in anticipation of a new cardiovascular approval.
Already under shareholder pressure, AMAG faces an uncertain future after an advisory panel recommended the FDA pull Makena from the U.S. market.
GlaxoSmithKline won an FDA panel recommendation for its over-the-counter nicotine spray—but the backing didn’t come easy.
Amarin’s Vascepa has ridden a wave of good news as it approached a label expansion review. Now, a bit of bad news: the FDA wants a closer look.