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…
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 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 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 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 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 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 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 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 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…
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