In the News

In this response, Roy and colleagues explain the model’s rationale, noting that its overall objective was to provide a framework for future use.
Inflectra is approved for several indications, similar to its originator, including severe plaque psoriasis, and active ankylosing spondylitis or psoriatic arthritis.
On March 30, 2016, the US Food and Drug Administration (FDA) approved defibrotide sodium (Defitelio; Jazz Pharmaceuticals) for the treatment of children and adult patients with hepatic veno-occlusive disease plus kidney or lung abnormalities after hematopoietic stem-cell transplantation. This is the first drug to be approved by the FDA for patients with severe hepatic veno-occlusive disease.
On March 11, 2016, the US Food and Drug Administration (FDA) approved an expanded indication for crizotinib (Xalkori; Pfizer) for the treatment of patients with metastatic non−small-cell lung cancer (NSCLC) that harbors the ROS-1 genetic mutation. Crizotinib is the first and only FDA-approved treatment for this patient population; the drug blocks ROS-1 protein activity in tumors, with the potential to prevent NSCLC tumors from spreading.
On March 4, 2016, the US Food and Drug Administration (FDA) approved a new type of coagulation factor IX (recombinant), albumin fusion protein (Idelvion; CSL Behring), for use in children and adults with hemophilia B. Used to replace a naturally occurring clotting factor functionally deficient or defective in these patients, this is the first coagulation factor-albumin fusion protein drug to be approved by the FDA.
Omnigraft (Integra Omnigraft Dermal Regeneration Matrix) has been approved by the FDA to treat patients with diabetes who have certain foot ulcers. The device, which is made of silicone, cow collagen, and shark cartilage, provides an environment for new skin and tissue to regenerate and heal the wound when placed over an ulcer.
Fluad, a trivalent vaccine produced using 3 flu virus strains—2 subtype A and 1 type B—has been approved for the prevention of seasonal influenza in patients aged ≥65 years. The vaccine was approved using the accelerated approval regulatory pathway.
Sugammadex (Bridion) injection has been approved by the US Food and Drug Administration to reverse the effects of neuromuscular-blocking drugs (rocuronium bromide and vecuronium bromide) used during tracheal intubation in adults. This injection may help patients recover from these drugs sooner.
Uridine triacetate (Vistogard) has been approved by the US Food and Drug Administration for emergency treatment of patients who receive an overdose of fluorouracil or capecitabine, or those who develop severe toxicities within 4 days of treatment with either therapy.
The US Food and Drug Administration has approved the oral drug alectinib (Alecensa) for the treatment of patients with metastatic, ALK-positive, non−small-cell lung cancer (NSCLC) who could not tolerate, or whose disease worsened after, receiving therapy with crizotinib (Xalkori).
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