Gene therapy will be approved by the FDA:

? The US Food and Drug Administration (FDA) has approved revisions to the safety labeling, adding adverse event information for use of insulin glulisine [rDNA origin] injection in pediatric patients; boxed warnings regarding serious infusion reactions,

Equity Research, doesn't see Merck's drug having a huge impact on Amgen. 'Even if does get FDA approval, it's not as imminent a threat as might be believed,' he said. For one thing, the FDA has not established the rules that will govern approvals. That

prescriptions were written in the U.S. in 2007, according to IMS Health. Larry Lesko, director of the FDA's office of clinical pharmacology, said the agency is in discussions with Plavix's maker, Bristol-Myers Squibb Co., about updating the label.

likely genetic factor inhibiting the drug's efficacy - but that has opened up more questions than the FDA, physicians, patients, insurance companies and the firm that sells Plavix can answer. Any labeling changes to Plavix, the second-highest selling

their side effects are found practical, useful or desirable. Botox, a paralytic agent, was originally approved by the FDA in 1989 to treat nerve spasms, particularly around the eye, which caused crossed eyes or uncontrollable blinking. But users