FDA approves Abbott's Vysis ALK FISH test for NSCLC therapy selection
Abbott today announced it has received approval from the U.S. Food and Drug Administration (FDA) for a new molecular diagnostic test designed to detect rearrangements of the anaplastic lymphoma kinase (ALK) gene in non-small-cell lung cancer.

FDA, industry reach generic drug fee agreement
WASHINGTON (Reuters) - U.S. regulators and generic drugmakers have reached a compromise agreement for a user-fee program that would require the companies to pay some $299 million in the first year to accelerate drug approvals.