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The U.S. Food and Drug Administration today approved a drug for the treatment of Peyronie's disease, a medical condition that causes severe curvature of the penis.
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Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration has approved Sovaldi 400 mg tablets, a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitisi 1 2C infection as a component of a combination antiviral treatment regimen.
University of Minnesota's president has agreed to an outside review of clinical research practices in the wake of the 2004 death of a man who committed suicide while enrolled in a drug study.
Federal health officials have approved a highly anticipated hepatitis C drug from Gilead Sciences Inc. that is expected to offer a faster, more palatable cure to millions of people infected with the liver-destroying virus.
The Food and Drug Administration on Friday approved the first drug to treat an unusual condition that causes painful, curved erections in men.
Late last month , the FDA demanded 23andMe in a warning letter to stop marketing its DNA testing device.
A lawsuit alleging that the US FDA unlawfully detained a batch of acetaminophen API destined for CMO Gemini Pharmaceuticals could have significant impact on the drug industry's definition of an 'end user.'
An experimental drug for ulcerative colitis and Crohn's disease from Takeda Pharmaceutical Co could pose risk of a potentially fatal brain infection called PML even though the problem has not been seen in clinical trials, staff members of the U.S. Food and Drug Administration said on Thursday.
Evidence that the levonorgestrel emergency contraceptive is less effective in overweight women is being reviewed by the Food and Drug Administration, which will determine whether this information should be added to the U.S. labeling of the product.
A legal case over access to details of clinical trials held by Europe's drugs regulator - sparked by two U.S. firms wanting to keep their data secret - has been hit by delay after the EU's top court sent it back to be re-examined by a lower body.
A report from the U.S. Food and Drug Administration says the Idaho Department of Agriculture spotted moldy yogurt during a routine inspection at a Chobani facility in Twin Falls two months before the company issued a voluntary recall.
Jubilant HollisterStier accounted for 7 per cent of Jubilant Life Science's consolidated sales in the six months ended September.
A screenshot from an Infusomat training video warns of the danger of a "free flow" of drugs pouring from the machine if loaded improperly.
MiMedx Group, Inc. , an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, provided an update today on its continuing discussions with the Food & Drug Administration regarding the regulatory classification of its micronized products.
The University of California, Santa Barbara is experiencing a meningitis outbreak a lot like the one that hit Princeton earlier this year.
Kids around the country are heading for school. For parents, now is the time to think about providing nutritious meals in kids' lunch boxes and on the kitchen table keeping them energized and focused throughout the day, and above all else, healthy.