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…
News
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 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 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…
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.…