An FDA Advisory Panel has given Theravance's telavancin a tentative nod. Telavancin is the long-hoped for treatment for superbugs like methicillin-resistant Staphylococcus aureus (MRSA).
Although, it's very important to note that the FDA Panel has requested a risk management program for the drug and women of child-bearing age.
“Today's positive outcome is a significant milestone for telavancin, an important potential weapon against serious bacterial infections,” said Rick E Winningham, Chief Executive Officer of Theravance. “We will continue to work closely with the FDA as they complete their review of the telavancin NDA.”
It's worth noting that a positive advisory committee recommendation is not sufficient to receive FDA approval (evidenced by the FDA's decision on Dendreon's Provenge).
See Theravance press release