FDA approves first generic versions of CymbaltaOn 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 pancreasOn 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 disorderOn 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 epilepsyThe 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 AEDsOn 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 devicesOn 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 extended-release, single-entity hydrocodone productOn 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 leukemiaOn 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 KitsOn 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 useOn 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 patientsOn 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 depressionOn Sept. 30, the U.S. Food and Drug Administration (FDA) approved Brintellix (vortioxetine) to treat adults with major depressive disorder. Read more.
FDA approves first generic versions of CymbaltaOn 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 pancreasOn 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 disorderOn 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 epilepsyThe 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 AEDsOn 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 devicesOn 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 productOn 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 leukemiaOn 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 KitsOn 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 useOn 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 patientsOn 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 depressionOn Sept. 30, the U.S. Food and Drug Administration (FDA) approved Brintellix (vortioxetine) to treat adults with major depressive disorder. Read more.
