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FDA approves Merck’s Keytruda for patients who have a specific biomarker
WASHINGTON — The Food and Drug Administration on Tuesday granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.
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FDA approves first drug targeting giant cell arteritis
WASHINGTON — The Food and Drug Administration on Monday expanded the approved use of Hoffman La Roche’s subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis. This new indication provides the first FDA-approved therapy, specific to this type of vasculitis.