- Senate passes Drug Quality and Security Act
- 21 health industry groups address FDA on proposed changes to generic drug label rules
- FDA approves Bristol-Myers Squibb's, AstraZeneca's Farxiga
- USPLabs agrees to recall and destroy dietary supplement following FDA actions
- FDA approves Mekinist in combination with Tafinlar to treat patients with advanced melanoma
PRINCETON, N.J. The Food and Drug Administration has agreed to expedite review of an investigational treatment for skin cancer.
Bristol-Myers Squibb announced Wednesday that the FDA had given priority-review designation to its application for ipilimumab, for treating adults with advanced melanoma who have received previous treatment. The FDA grants the designation to drugs that it considers to offer major advances in treatment of a disease or provide treatment options where no adequate therapy exists.
Bristol-Myers Squibb expected the FDA to take action on ipilimumab in late December.