FDA allows marketing of ‘next generation’ gene sequencing devices
On Nov. 19, the U.S. Food and Drug Administration (FDA) allowed marketing of four diagnostic devices that can be used for high throughput gene…
News
FDA approves extended-release, single-entity hydrocodone product
On Oct. 25, the U.S. Food and Drug Administration (FDA) approved Zohydro ER (hydrocodone bitartrate extended-release capsules) for the management of pain severe enough…
FDA approves Gazyva for chronic lymphocytic leukemia
On Nov. 1, the U.S. Food and Drug Administration (FDA) approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously…
Recall of MedStream Programmable Infusion Pump and Refill Kits
On Oct. 23, the U.S. Food and Drug Administration (FDA) noted that Codman & Shrutleff, Inc., has recalled its MedStream Programmable Pump and MedStream…
FDA approves Liposorber Apheresis System for pediatric use
On Oct. 10, the U.S. Food and Drug Administration (FDA) approved Liposorber LA-15 System to treat pediatric patients with primary focal segmental glomerulosclerosis (FSGS)…
FDA expands access to artificial heart valve to inoperable patients
On Sept. 23, the U.S. Food and Drug Administration (FDA) approved revised labeling for the Sapien Transcatheter Heart Valve (THV), making the device available…
FDA approves Brintellix for major depression
On Sept. 30, the U.S. Food and Drug Administration (FDA) approved Brintellix (vortioxetine) to treat adults with major depressive disorder. Read more.
FDA approved Adempas for pulmonary hypertension
On Sept. 30, the U.S. Food and Drug Administration (FDA) approved Adempas (riociguat) to treat adults with two forms of pulmonary hypertension. Read more.
FDA issues final guidance for mobile medical apps
On Sept. 23, the U.S. Food and Drug Administration (FDA) issued final guidance for developers of mobile medical apps. The agency has cleared about…
FDA approves first generic capecitabine to treat breast and colorectal cancers
On Sept. 16, the U.S. Food and Drug Administration (FDA) approved the first generic version of Xeloda (capecitabine), used to treat metastatic breast and…
Preventing feeding tube misconnections
The U.S. Food and Drug Administration (FDA) has a website dedicated to the issue of tubing and Luer misconnections. The website includes a special…
FDA approves first nonhormonal treatment for hot flashes
On June 28, the U.S. Food and Drug Administration (FDA) approved Brisdelle (paroxetine) to treat moderate to severe hot flashes associated with menopause. Brisdelle,…
FDA allows marketing of ‘next generation’ gene sequencing devices
On Nov. 19, the U.S. Food and Drug Administration (FDA) allowed marketing of four diagnostic devices that can be used for high…
FDA approves extended-release, single-entity hydrocodone product
On Oct. 25, the U.S. Food and Drug Administration (FDA) approved Zohydro ER (hydrocodone bitartrate extended-release capsules) for the management of pain…
FDA approves Gazyva for chronic lymphocytic leukemia
On Nov. 1, the U.S. Food and Drug Administration (FDA) approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients…
Recall of MedStream Programmable Infusion Pump and Refill Kits
On Oct. 23, the U.S. Food and Drug Administration (FDA) noted that Codman & Shrutleff, Inc., has recalled its MedStream Programmable Pump…
FDA approves Liposorber Apheresis System for pediatric use
On Oct. 10, the U.S. Food and Drug Administration (FDA) approved Liposorber LA-15 System to treat pediatric patients with primary focal segmental…
FDA expands access to artificial heart valve to inoperable patients
On Sept. 23, the U.S. Food and Drug Administration (FDA) approved revised labeling for the Sapien Transcatheter Heart Valve (THV), making the…
FDA approves Brintellix for major depression
On Sept. 30, the U.S. Food and Drug Administration (FDA) approved Brintellix (vortioxetine) to treat adults with major depressive disorder. Read more.
FDA approved Adempas for pulmonary hypertension
On Sept. 30, the U.S. Food and Drug Administration (FDA) approved Adempas (riociguat) to treat adults with two forms of pulmonary hypertension.…
FDA issues final guidance for mobile medical apps
On Sept. 23, the U.S. Food and Drug Administration (FDA) issued final guidance for developers of mobile medical apps. The agency has…
FDA approves first generic capecitabine to treat breast and colorectal cancers
On Sept. 16, the U.S. Food and Drug Administration (FDA) approved the first generic version of Xeloda (capecitabine), used to treat metastatic…
Preventing feeding tube misconnections
The U.S. Food and Drug Administration (FDA) has a website dedicated to the issue of tubing and Luer misconnections. The website includes…
FDA approves first nonhormonal treatment for hot flashes
On June 28, the U.S. Food and Drug Administration (FDA) approved Brisdelle (paroxetine) to treat moderate to severe hot flashes associated with…
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