2 days ago
The FDA said Wednesday it approved the drug, Xofigo from Bayer Pharmaceuticals, for men whose cancer has grown into bone tumors even after receiving medication or surgery to lower testosterone.
4 days ago
The test approved by the FDA is one of a number of "cobas" diagnostics developed by Roche.
8 days ago
But Health and Human Services Secretary Kathleen Sebelius overruled the recommendation, and the FDA later rejected a petition calling for unrestricted over-the-counter sales of the drug.
9 days ago
State pharmacy boards back more FDA oversight
10 days ago
The St. Petersburg, Fla.-based pharmacy has agreed to recall all of its sterile drugs and is in the process of notifying customers, the FDA said in a statement.
10 days ago
In March, the Whitehouse Station, N.J., company said the FDA was reviewing its application for an immunotherapy tablet for grass pollen allergies.
12 days ago
I have to diagnose too many young people with melanoma and see the grief that it causes to these families," said Dr. Mary Maloney of the American Academy of Dermatology, on a call with FDA...
12 days ago
But the FDA said it is adding new warnings to the drugs' labeling after a study showed they decreased IQ scores in children whose mothers took them while pregnant.
17 days ago
U.S. District Judge Edward Korman of New York had given the FDA until Monday to lift all age limits on Plan B and a cheaper generic, mandating that emergency contraception be sold just like aspirin.
18 days ago
The U.S. Food and Drug Administration on Tuesday approved the sale of the emergency contraceptive Plan B One-Step for sale without a prescription to women ages 15 and over.
18 days ago
Tuesday, the FDA lowered to 15 the age at which girls and women can buy the emergency contraceptive without a prescription - and said it no longer has to be kept behind pharmacy counters.
61 days ago
The Food and Drug Administration is warning doctors and hospital managers about a nationwide recall of all drugs made by a New Jersey compounding pharmacy because they may be contaminated with mold.
65 days ago
The Food and Drug Administration is looking into evidence that a group of new diabetes drugs can increase the risk of pancreatitis and other problems.
66 days ago
The U.S. Food and Drug Administration said Wednesday that Edison-based Butterfly Bakery has agreed under a consent decree to shut down until it can meet all regulations.
67 days ago
The FDA's action could convince doctors to choose other options for people prone to heart problems, though the new label notes that some other antibiotics have similar effects on the heart.
67 days ago
The FDA has tentatively said the rules are due this spring, but that deadline may be optimistic as the food industry and regulators continue to haggle over how they will be written.
79 days ago
If prices were set with FDA approval, to help keep rates at what the market can reasonably bear, costs would likely be significantly lower.
79 days ago
The FDA has said the across-the-board cuts due Friday mean 2,100 fewer food safety inspections this year, though Hamburg said in an interview with The Associated Press that the number is an estimate.
81 days ago
The Food and Drug Administration on Tuesday approved the first pill-based drug for women who experience pain during sex because of menopause.
81 days ago
The FDA says in a statement it is unclear whether Amgen's drug had a role in the patient's death, but it is reminding doctors to prescribe it carefully.
84 days ago
The FDA approved the new treatment for about 20 percent of breast cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy.
85 days ago
A Food and Drug Administration veteran who helped spearhead efforts to regulate the tobacco industry in the 1990s is taking over the agency's Center for Tobacco Products.
86 days ago
The story should have noted that companies can also make GRAS determinations without notifying the FDA.
93 days ago
The Food and Drug Administration says U.S. marshals have seized illegal dietary supplements from a Florida company because some may contain a dangerous pharmaceutical ingredient.
95 days ago
While the USDA oversees meat safety and is required to have a constant presence at meatpacking plants, the FDA conducts infrequent inspections at manufacturing facilities for most other foods.
