News
On Feb. 20, 2013, the U.S. Food and Drug Administration (FDA) approved the Argus II Retinal Prosthesis System, the first implanted device to treat…
FDA approves Osphena for postmenopausal women with dyspareunia
On Feb. 26, 2013, the U.S. Food and Drug Administration (FDA) approved Osphena (ospemifene) to treat women with moderate to severe dyspareunia (pain during…
FDA approves new drug treatments for type 2 diabetes
On Jan. 25, 2013, the U.S. Food and Drug Administration (FDA) approved three new related products for the treatment of type 2 diabetes: Nesina…
FDA approves seasonal flu vaccine made using novel technology
On Jan. 16, 2012, the U.S. Food and Drug Administration (FDA) approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus)…
FDA approves Botox for treatment of overactive bladder
On Jan. 18, 2013, the U.S. Food and Drug Administration (FDA) approved the use of Botox (onabotulinumtoxinA) to treat adults with overactive bladder who…
FDA approves first anti-diarrheal drug for HIV/AIDS patients
On Dec. 31, 2012, the U.S. Food and Drug Administration (FDA) approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral…
FDA approves drug to treat multi-drug resistant TB
On Dec. 31, 2012, the U.S. Food and Drug Administration (FDA) approved Sirturo (bedaquiline) as part of combination therapy to treat adults with multi-drug…
FDA requires lower recommended doses for drugs containing zolpidem
On Jan. 10, 2012, the U.S. Food and Drug Administration (FDA) announced it is requiring the manufacturers of Ambien, Ambien CR, Edluar and Zolpimist,…
FDA issue draft guidance on making opioids harder to abuse
On Jan. 9, 2012, the U.S. Food and Drug Administration (FDA) issued a draft guidance document to assist industry in developing new formulations of…
FDA permits marketing of device to seal lung punctures
On Dec. 19, the U.S. Food and Drug Administration allowed marketing of the Bio-Seal Lung Biopsy Tract Plug System, a device that seals punctures…
FDA expands Zytiga’s use for late-stage breast cancer
On Dec. 10, the U.S. Food and Drug Administration expanded the approved use of Zytiga (abiraterone acetate) to treat men with metastatic castration-resistant prostate…
FDA approves first flu vaccine using new manufacturing technique
On Nov. 20, the U.S. Food and Drug Administration (FDA) approved Flucelvax, the first seasonal influenza vaccine licensed in the United States produced using…
FDA approves first retinal implant for adults with advanced retinitis pigmentosa
On Feb. 20, 2013, the U.S. Food and Drug Administration (FDA) approved the Argus II Retinal Prosthesis System, the first implanted device…
FDA approves Osphena for postmenopausal women with dyspareunia
On Feb. 26, 2013, the U.S. Food and Drug Administration (FDA) approved Osphena (ospemifene) to treat women with moderate to severe dyspareunia…
FDA approves new drug treatments for type 2 diabetes
On Jan. 25, 2013, the U.S. Food and Drug Administration (FDA) approved three new related products for the treatment of type 2…
FDA approves seasonal flu vaccine made using novel technology
On Jan. 16, 2012, the U.S. Food and Drug Administration (FDA) approved Flublok, the first trivalent influenza vaccine made using an insect…
FDA approves Botox for treatment of overactive bladder
On Jan. 18, 2013, the U.S. Food and Drug Administration (FDA) approved the use of Botox (onabotulinumtoxinA) to treat adults with overactive…
FDA approves first anti-diarrheal drug for HIV/AIDS patients
On Dec. 31, 2012, the U.S. Food and Drug Administration (FDA) approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients…
FDA approves drug to treat multi-drug resistant TB
On Dec. 31, 2012, the U.S. Food and Drug Administration (FDA) approved Sirturo (bedaquiline) as part of combination therapy to treat adults…
FDA requires lower recommended doses for drugs containing zolpidem
On Jan. 10, 2012, the U.S. Food and Drug Administration (FDA) announced it is requiring the manufacturers of Ambien, Ambien CR, Edluar…
FDA issue draft guidance on making opioids harder to abuse
On Jan. 9, 2012, the U.S. Food and Drug Administration (FDA) issued a draft guidance document to assist industry in developing new…
FDA permits marketing of device to seal lung punctures
On Dec. 19, the U.S. Food and Drug Administration allowed marketing of the Bio-Seal Lung Biopsy Tract Plug System, a device that…
FDA expands Zytiga’s use for late-stage breast cancer
On Dec. 10, the U.S. Food and Drug Administration expanded the approved use of Zytiga (abiraterone acetate) to treat men with metastatic…
FDA approves first flu vaccine using new manufacturing technique
On Nov. 20, the U.S. Food and Drug Administration (FDA) approved Flucelvax, the first seasonal influenza vaccine licensed in the United States…
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