FDA issue draft guidance on making opioids harder to abuse
On Jan. 9, 2012, the U.S. Food and Drug Administration (FDA) issued a draft guidance document to assist industry in developing new formulations of…
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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 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 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 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…
Single-dose IV Zofran pulled from market
On Dec. 4, the U.S. Food and Drug Administration announced that the 32 mg, single IV dose of the anti-nausea drug Zofran (ondansetron hydrochloride)…
FDA approves Xeljanz for rheumatoid arthritis
On Nov. 6, the U.S. Food and Drug Administration (FDA) approved Xeljanz (tofacitinib) to treat adults with moderately to severely active rheumatoid arthritis who…
FDA approves first subcutaneous cardiac defibrillator
On Sept. 28, the U.S. Food and Drug Administration (FDA) approved the first subcutaneously inserted cardiac defibrillator: Subcutaneous Implantable Defibrillator (S-ICD) System. Read more.
FDA approves Synribo for chronic myelogenous leukemia
On Oct. 26, the U.S. Food and Drug Administration (FDA) approved Synribo (omacetaxine mepesuccinate) for the treatment of adults with chronic myelogenous leukemia. Synribo…
FDA marks 50 years of Kefauver-Harris amendment
This year the U.S. Food and Drug Administration (FDA) is marking the anniversary of the Kefauver-Harris amendment, passed 50 years ago. The legislation gave…
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 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 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 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 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…
Single-dose IV Zofran pulled from market
On Dec. 4, the U.S. Food and Drug Administration announced that the 32 mg, single IV dose of the anti-nausea drug Zofran…
FDA approves Xeljanz for rheumatoid arthritis
On Nov. 6, the U.S. Food and Drug Administration (FDA) approved Xeljanz (tofacitinib) to treat adults with moderately to severely active rheumatoid…
FDA approves first subcutaneous cardiac defibrillator
On Sept. 28, the U.S. Food and Drug Administration (FDA) approved the first subcutaneously inserted cardiac defibrillator: Subcutaneous Implantable Defibrillator (S-ICD) System.…
FDA approves Synribo for chronic myelogenous leukemia
On Oct. 26, the U.S. Food and Drug Administration (FDA) approved Synribo (omacetaxine mepesuccinate) for the treatment of adults with chronic myelogenous…
FDA marks 50 years of Kefauver-Harris amendment
This year the U.S. Food and Drug Administration (FDA) is marking the anniversary of the Kefauver-Harris amendment, passed 50 years ago. The…
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