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FDA Regulations

The U.S. Food and Drug Administration approved Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV...

The U.S. Food and Drug Administration approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung...

The U.S. Food and Drug Administration recently expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients...

The U.S. Food and Drug Administration granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with.

DxNA has received Food and Drug Administration (FDA) approval for Coccidioides test, making this the first FDA-authorized...

The U.S. Food and Drug Administration approved a new mechanical valve (15mm), small enough to be used in newborn pediatric...

The U.S. Food and Drug Administration approved the first contact lenses that can act like sunglasses.

A special additive automatically darkens...

The U.S. Food and Drug Administration cleared the use of the Trevo clot retrieval device to treat patients with acute ischemic...

The U.S. Food and Drug Administration  permitted marketing of the first medical device to use artificial intelligence to detect greater than...

The US FDA has approved the orphan drug burosumab (Crysvita, Ultragenyx Pharmaceutical Inc) to treat adults and children age 1 year and older with X...

FDA is advising caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased...

FDA authorized the first test to identify the emerging pathogen Candida auris (C. auris), which can cause serious infections in hospitalized patients...

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