News
On April 3, the U.S. Food and Drug Administration (FDA) approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise,…
FDA approves new implantable hearing device
On March 20, the U.S. Food and Drug Administration (FDA) approved the first implantable device for people 18 and older with severe or profound…
FDA allows marketing of first device to prevent migraine headaches
On March 11, the U.S. Food and Drug Administration (FDA) allowed marketing of the first device as a preventative treatment for migraine headaches. This…
FDA approves Impavido to treat leishmaniasis
On March 19, the U.S. Food and Drug Administration (FDA) approved Impavido (miltefosine) to treat a tropical disease called leishmaniasis. Read more.
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…
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 approves Tanzeum to treat type 2 diabetes
On April 3, the U.S. Food and Drug Administration (FDA) approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet…
FDA approves new implantable hearing device
On March 20, the U.S. Food and Drug Administration (FDA) approved the first implantable device for people 18 and older with severe…
FDA allows marketing of first device to prevent migraine headaches
On March 11, the U.S. Food and Drug Administration (FDA) allowed marketing of the first device as a preventative treatment for migraine…
FDA approves Impavido to treat leishmaniasis
On March 19, the U.S. Food and Drug Administration (FDA) approved Impavido (miltefosine) to treat a tropical disease called leishmaniasis. Read more.
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)…
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