fda panel

WASHINGTON (MedPage Today) -- An FDA advisory panel punted on the question of approval for an inhaled version of the antipsychotic drug loxapine (Adasuve) to treat agitation in bipolar and schizophrenic patients, despite the risk for respiratory side effects.

An FDA panel voted 15-11 that the benefits of newer oral contraceptives outweigh their risks of dangerous blood clots.

WASHINGTON (MedPage Today) -- An FDA advisory panel overwhelmingly agreed that an implantable pulmonary artery pressure monitoring device was safe, but was not convinced about its effectiveness and benefit-risk ratio.

(MedPage Today) -- SILVER SPRING, Md. -- An FDA advisory committee has voted 14-1 in favor of expanding the indication for the pneumococcal 13-valent conjugate vaccine (Prevnar 13) to include use in adults 50 and older.

WASHINGTON (MedPage Today) -- The pneumococcal 13-valent conjugate vaccine (Prevnar 13) -- currently approved only for children -- appears safe and effective at preventing pneumococcal disease in adults 50 and older, FDA reviewers concluded in advance of an advisory committee meeting Wednesday.

Labels on bisphosphonates, a type of medication used to treat and prevent osteoporosis, should further clarify how long patients can take them, an FDA advisory panel voted today.

TRENTON, N.J. (AP) -- Food and Drug Administration advisers voted Friday to require makers of widely used osteoporosis drugs to clarify how long patients should take them for the greatest benefit and least risk....

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Medicare will keep paying for the drug Avastin to fight breast cancer even though an FDA panel has recommended that the medication no longer be sold as a treatment for breast cancer.

(MedPage Today) -- GAITHERSBURG, Md. -- An FDA advisory panel narrowly recommended approval for an investigational bone graft device that uses a growth factor protein to regrow bones in the foot and ankle.