The U.S. Food and Drug Administration today cleared for marketing the Platelet PGD Test System, the first rapid test for the detection of bacterial contamination in pooled platelets derived from whole blood.
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FDA Clears First Rapid Test for Bacterial Contamination in Pooled Platelets
The U.S. Food and Drug Administration today approved Berinert, the first treatment for acute abdominal attacks and facial swelling associated with a rare and potentially life-threatening genetic disease called hereditary angioedema (HAE).
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FDA Approves Berinert to Treat Abdominal Attacks, Facial Swelling Associated With Hereditary Angioedema
The U.S. Food and Drug Administration today approved Mirena (levonorgestrel intrauterine system) to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention. This is the first intrauterine device approved by the FDA for this additional indication.
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FDA Approves Additional Use for IUD Mirena to Treat Heavy Menstrual Bleeding in IUD Users
The U.S. Food and Drug Administration has approved Folotyn (pralatrexate), the first treatment for a form of cancer known as Peripheral T-cell Lymphoma (PTCL), an often aggressive type of non-Hodgkins lymphoma.
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FDA Approves First Drug for Treatment of Peripheral T-cell Lymphoma
The U.S. Food and Drug Administration today approved the first generic version of the emergency contraceptive Plan B (levonorgestrel) tablets, 0.75 mg
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FDA Approves Generic Prescription-Only Version of Plan B Emergency Contraceptive for Women Ages 17 and Under