FDA approves Imbruvica to treat chronic lymphocytic leukemia
On Feb. 13, the U.S. Food and Drug Administration (FDA) expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia patients who have…
News
FDA approves Mekinist in combination with Tafinlar for advanced melanoma
On Jan. 10, the U.S. Food and Drug Administration (FDA) announced it had approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients…
FDA approves marketing of postnatal test for developmental disabilities
On Jan. 17, the U.S. Food and Drug Administration (FDA) announce that it has authorized for marketing the Affymetrix CytoScan Dx Assay, which can…
FDA approves first generic versions of Cymbalta
On Dec. 11, the U.S. Food and Drug Administration (FDA) approved the first generic versions of Cymbalta (duloxetine delayed-release capsules). Read more.
FDA approves new stent for treatment of pseudocysts of the pancreas
On Dec. 18, the U.S. Food and Drug Administration (FDA) allowed marketing of the AXIOS Stent and Delivery System for treating pseudocysts that form…
FDA approves new treatment for genetic coagulation disorder
On Dec. 18, the U.S. Food and Drug Administration (FDA) approved Tretten, Coagulation Factor XIII A-Subunit (Recombinant), the first recombinant product for use in…
FDA approves medical device for epilepsy
The U.S. Food and Drug Administration (FDA) has approved a device to help reduce the frequency of seizures in epilepsy patients who have not…
FDA issues safety communication for HeartStart AEDs
On Nov. 25, the U.S. Food and Drug Administration (FDA) issued a safety communication stating that certain HeartStart automated external defibrillator (AED) devices made…
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…
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…
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…
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 Imbruvica to treat chronic lymphocytic leukemia
On Feb. 13, the U.S. Food and Drug Administration (FDA) expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia patients…
FDA approves Mekinist in combination with Tafinlar for advanced melanoma
On Jan. 10, the U.S. Food and Drug Administration (FDA) announced it had approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to…
FDA approves marketing of postnatal test for developmental disabilities
On Jan. 17, the U.S. Food and Drug Administration (FDA) announce that it has authorized for marketing the Affymetrix CytoScan Dx Assay,…
FDA approves first generic versions of Cymbalta
On Dec. 11, the U.S. Food and Drug Administration (FDA) approved the first generic versions of Cymbalta (duloxetine delayed-release capsules). Read more.
FDA approves new stent for treatment of pseudocysts of the pancreas
On Dec. 18, the U.S. Food and Drug Administration (FDA) allowed marketing of the AXIOS Stent and Delivery System for treating pseudocysts…
FDA approves new treatment for genetic coagulation disorder
On Dec. 18, the U.S. Food and Drug Administration (FDA) approved Tretten, Coagulation Factor XIII A-Subunit (Recombinant), the first recombinant product for…
FDA approves medical device for epilepsy
The U.S. Food and Drug Administration (FDA) has approved a device to help reduce the frequency of seizures in epilepsy patients who…
FDA issues safety communication for HeartStart AEDs
On Nov. 25, the U.S. Food and Drug Administration (FDA) issued a safety communication stating that certain HeartStart automated external defibrillator (AED)…
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 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…
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…
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…
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