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A Johnson & Johnson drug won Food and Drug Administration approval Monday for treating the incurable blood cancer multiple myeloma in patients who’ve failed prior therapies and have few options left. Darzalex is the first biologic drug and first monoclonal antibody — a genetically engineered drug designed to target diseased tissue and spare healthy cells — approved for multiple myeloma. (Johnson, 11/16)

A new front is emerging in the fight against antibiotic-resistant superbugs—one that doesn’t involve the development of new drugs. Companies are racing to develop diagnostic technologies that can be used by hospitals and clinics to pinpoint the cause of common infections quickly. That should cut down on the unnecessary prescription of antibiotics, a major driver of drug-resistance in bacteria. (Roland, 11/16)

The Food and Drug Administration, in a report released on the eve of a congressional hearing Tuesday, said that certain laboratory tests “may have caused or have caused” actual harm to patients by producing erroneous results. At issue are so-called lab-developed tests, or LDTs, which are produced and performed within a single hospital or corporate laboratory. Such tests are often done on tissue samples sent in from outside doctors and hospitals. They are distinct from standard diagnostic equipment and products that are sold to doctors’ offices, hospitals or other labs. (Burton, 11/16)