FDA approves new indication for imaging agent
On June 13, the U.S. Food and Drug Administration (FDA) a new use for Lymphoseek (technetium 99m tilmanocept) Injection, a radioactive diagnostic imaging agent…
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FDA approves new drug for serious skin infections
On June 20, the U.S. Food and Drug Administration (FDA) approved Sivextro (tedizolid phosphate) to treat patients with acute bacterial skin and skin structure…
FDA approves Zykadia for NSCLC
On April 29, the U.S. Food and Drug Administration (FDA) approved Zykadia for patients with a certain type of late-stage non-small cell lung cancer…
FDA approves Topamax for migraine prevention in adolescents
On March 28, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention of migraine headaches in adolescents ages 12 to 17. This…
FDA allows marketing of military dressing
On April 3, the U.S. Food and Drug Administration (FDA) announced it is allowing marketing of an expandable, multi-sponge wound dressing to control the…
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 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 new indication for imaging agent
On June 13, the U.S. Food and Drug Administration (FDA) a new use for Lymphoseek (technetium 99m tilmanocept) Injection, a radioactive diagnostic…
FDA approves new drug for serious skin infections
On June 20, the U.S. Food and Drug Administration (FDA) approved Sivextro (tedizolid phosphate) to treat patients with acute bacterial skin and…
FDA approves Zykadia for NSCLC
On April 29, the U.S. Food and Drug Administration (FDA) approved Zykadia for patients with a certain type of late-stage non-small cell…
FDA approves Topamax for migraine prevention in adolescents
On March 28, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention of migraine headaches in adolescents ages 12 to…
FDA allows marketing of military dressing
On April 3, the U.S. Food and Drug Administration (FDA) announced it is allowing marketing of an expandable, multi-sponge wound dressing to…
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,…
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