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…
News
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 approves new drug for irritable bowel syndrome and constipation
On Aug. 30, the U.S. Food and Drug Administration (FDA) approved Linzess (linaclotide) to treat chronic idiopathic constipation and to treat irritable bowel syndrome…
FDA approves Marqibo for rare type of leukemia
On Aug. 9, the U.S. Food and Drug Administration (FDA) approved Marqibo (vincristine sulfate liposome injection) to treat adults with Philadelphia chromosome negative (Ph-)…
FDA approves Lucentis for diabetic macular edema
On Aug. 10, the U.S. Food and Drug Administration (FDA) approved Lucentis (ranibizumab injection) for the treatment of diabetic macular edema. Read more.
FDA warns of risk of death from postop codeine use in children
On Aug. 15, the U.S. Food and Drug Administration (FDA) issued a warning about risk of death from postop codeine use in children following…
FDA approves new weight-loss drug
On July 17, the U.S. Food and Drug Administration (FDA) approved Qsymia (phentermine and topiramate extended-release) as an addition to a reduced-calorie diet and…
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…
FDA approves new drug for irritable bowel syndrome and constipation
On Aug. 30, the U.S. Food and Drug Administration (FDA) approved Linzess (linaclotide) to treat chronic idiopathic constipation and to treat irritable…
FDA approves Marqibo for rare type of leukemia
On Aug. 9, the U.S. Food and Drug Administration (FDA) approved Marqibo (vincristine sulfate liposome injection) to treat adults with Philadelphia chromosome…
FDA approves Lucentis for diabetic macular edema
On Aug. 10, the U.S. Food and Drug Administration (FDA) approved Lucentis (ranibizumab injection) for the treatment of diabetic macular edema. Read…
FDA warns of risk of death from postop codeine use in children
On Aug. 15, the U.S. Food and Drug Administration (FDA) issued a warning about risk of death from postop codeine use in…
FDA approves new weight-loss drug
On July 17, the U.S. Food and Drug Administration (FDA) approved Qsymia (phentermine and topiramate extended-release) as an addition to a reduced-calorie…
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