Topic: FDA advisory committee
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.
Gilead’s Descovy secured backing from an FDA panel for HIV prevention in men and transgender women. But beyond that, it ran into issues.
As FDA panel experts gear up to debate the merits of Gilead’s Descovy for PrEP, the question isn't whether it’s worthy of an indication in men.
For years, Amarin promised that its fish-oil drug Vascepa could evolve into a blockbuster. Now, analysts are finally seeing major sales on the horizon.