U.S. regulators have approved the first drug for an aggressive kind of multiple sclerosis that steadily reduces coordination and the ability to walk. The Food and Drug Administration approved Ocrevus … Click to Continue »
After being unceremoniously dropped from President Donald Trump's transition team, New Jersey Gov. Chris Christie is dipping his toes into the administration by taking the lead of a White House … Click to Continue »
At long last, and for the first time in medical history, people with both relapsing and primary progressive forms of multiple sclerosis have reason to celebrate. The U.S. Food and Drug Administration (FDA) today approved Ocrevus (ocrelizumab) as a disease-modifying therapy for both forms of MS, a chronic autoimmune disease. Show More Summary
(Reuters) - The U.S. Food and Drug Administration (FDA) on Tuesday approved Roche Holding AG's multiple sclerosis (MS) drug Ocrevus, putting the potential blockbuster drug back on track after a delay by regulators over manufacturing issues.
(Reuters) - The U.S. Food and Drug Administration on Tuesday approved Regeneron Pharmaceuticals Inc and Sanofi SA's drug for moderate-to-severe atopic dermatitis, a product widely seen as the most important future growth driver for the two companies.
A seafood processing plant in Malaysia owned by TS Food Industry Sdn. Bhd. is in serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations of the U.S. Food and Drug Administration. An FDA inspection team visited the facility Oct. 18 and 19, 2016m finding problems that the company did not adequately... Continue Reading
The American Pizza Community held a meeting in the nation’s capital on Wednesday to sound the alarm over the Food and Drug Administration’s...
Vitamin D and potassium are among the nutrients that will be required on the updated nutrition facts label for packaged foods. The U.S. Food and Drug Administration says that’s because Americans don’t always get the recommended amounts of these nutrients. Calcium and iron information will continue to be required on the labels. In this Mayo Clinic Radio […]
The U.S. Food and Drug Administration yesterday granted accelerated approval to the checkpoint inhibitor Bavencio (avelumab) for the treatment of patients with metastatic Merkel cell carcinoma. Dr. Paul Nghiem, a senior investigatorShow More Summary
(Fred Hutchinson Cancer Research Center) The US Food and Drug Administration yesterday granted accelerated approval to the checkpoint inhibitor Bavencio (avelumab) for the treatment of patients with metastatic Merkel cell carcinoma (MCC), including those who have not received prior chemotherapy. Show More Summary
Twenty-eight states and the nation’s capital allow for the legal use of medical marijuana. The drug is legal for recreational use in eight states and Washington, D.C. But with a new administration in office signaling a crackdown on recreational...Show More Summary
A Kansas grower is recalling “Asian Mix Microgreens” from retailers in three states because a random sample tested by the Food and Drug Administration found Salmonella bacteria in the sprouts. The ChloroFields branded microgreens from ChloroFields of Lawrence, KS, have sell-by dates of March 26, so there is concern retailers and consumers may still have... Continue Reading
It’s not a question of if, but when, officials with the Food and Drug Administration will show up at any given food company for an unannounced inspection, with any violations outlined in a Form 483 that is handed off to company representatives as inspectors head out the door. While the Form 483 itself is essentially... Continue Reading
Nine women have died of a rare type of lymphoma that Food and Drug Administration officials now say may be caused by breast implants. This form of cancer, called breast implant-associated anaplastic large cell lymphoma (ALCL), has occurred more often in women with implants that are textured rather than smooth, the FDA said Tuesday. As of Feb. Show More Summary
A rare type of cancer believed to be caused by breast implants has now been linked to nine deaths. The Federal Drug Administration released an update on Tuesday to a 2011 report about a rare form of cancer, not linked to breast cancer, called anaplastic large cell lymphoma (ALCL), which included its findings over the last six years. Show More Summary
Though still rare, the potential risks are significant enough for the Food and Drug Administration to suggest limiting these drugs’ use to cases of absolute necessity.
The Food and Drug Administration found a concerning link between breast implants and a rare form of cancer that affects the surrounding lymph nodes. In a press release shared on March 22, the FDA said a total of nine people have died...Show More Summary
(Reuters) - Newron Pharmaceuticals SpA said on Tuesday the U.S. Food and Drug Administration approved its Parkinson's disease treatment Xadago as an add-on therapy to levodopa, a drug widely used to treat the disease.
The Food and Drug Administration last week shut shut down several Colorado dietary-supplement companies that it said were selling “misbranded and adulterated” products that wrongly purported to treat “high cholesterol, hypertension, diabetes, depression and muscle pain.” The agency said violations...
The U.S. Food and Drug Administration has issued new guidelines for manufacturers of home glucose monitoring devices. The old standard was that the glucose reading of the device had to be within 20% of the actual or true value compared to a medical lab-grade machine. For example, if the device read 165 mg/dL, the true […]