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FDA Approves Kidney Failure Device
FDA approves device to help kidney failure patients with dialysis-related-amyloidosis. Known as the Lixelle Beta-2 microglobulin Apheresis Column, the device is already in use in Japan, where it is manufactured.
First Biosimilar Approved
The US Food and Drug Administration (FDA) approved its first biosimilar product filgrastim-sndz (Zarxio/Sandoz), a cancer drug that is similar to Amgen’s filgrastim (Neupogen).
FDA Warning: Testosterone Can Kill
Manufacturers of prescription testosterone products must change their drug labels to include a warning about increased risk of heart attacks and strokes. The labeling change, announced today by the US Food and Drug Administration (FDA) addresses the use of testosterone by men whose decreased level of the hormone is due to aging.
CDC Adds Gardasil 9 to Routine Vaccination List
The US Centers for Disease Control and Prevention (CDC) advisory committee on immunization practices today approved including Merck's Gardasil 9 vaccine in a list of recommended vaccinations for children and young adults. The vaccine got US Food and Drug Administration (FDA) approval in December, 2014. The vaccine is an improvement on the older version of Gardasil in that it offers protection against 5 more types of Human Papillomavirus (HPV) than the original product.
New Antibacterial Approved for Complex Infections
The US Food and Drug Administration (FDA) approved a new antibacterial drug combination product, ceftazidime-avibactam (Avycaz/Forest Labs), for use in complicated intra-abdominal infections.
FDA Approves Ebola Rapid Test
The FDA has approved a rapid test for an Ebola antigen that can diagnose infection in people who are asymptomatic.

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