Government Agencies
FDA
FDA to decide on GW Pharma epilepsy drug by June 27. *Analysts eye potential $1 billion- plus Epidiolex sales. GW Pharmaceuticals, which has spent 20 years developing medicines from cannabis, is hoping for a Food and Drug Administration green light by June 27, after winning support from an advisory panel in April.
NEW YORK— A newer kind of flu vaccine only worked a little bit better in seniors this past winter than traditional shots, the government reported Wednesday. But these incremental improvements are very important, "said Brendan Flannery, a flu expert at the Centers for Disease Control and Prevention. The findings of the Food and Drug Administration study were...
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After receiving more than 3,000 comments on its draft plan, the FDA acknowledged that the labeling was confusing and that it would now come up with a revised approach for maple syrup and honey. "The feedback that FDA has received is that the approach laid out in the draft guidance does not provide the clarity that the FDA intended. It is important to FDA that...
Meat products grown by replicating animal cells are not yet on supermarket shelves, but the topic is getting enough attention that the Food and Drug Administration is holding a public meeting on "cultured" meat next month. The FDA says animal cells can currently be produced from "starter cells" in machines where the cells are cultured to grow.
The U.S. Food and Drug Administration is expected to decide by the end of the month whether to approve GW Pharmaceuticals' Epidiolex. The U.S. Drug Enforcement Administration has long categorized cannabis as a Schedule I drug, a category with "no currently accepted medical use and a high potential for abuse." She moved from Maine to Colorado in 2014 so she could...
Anne Wojcicki of 23andMe says growing up, she had a lot of independence.
NEW YORK— Are the fiber counts for foods getting bloated? Now, the U.S. Food and Drug Administration is giving its nod for many of the ingredients that companies already use to pump up fiber to be counted as such on the new Nutrition Facts panel, which will be required in two years. Since then, the FDA has been reviewing scientific evidence submitted by companies...
Kellogg Co is recalling over a million cases of cereal due to the potential for Salmonella contamination.
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June 15- Israel's Teva Pharmaceutical Inc said on Friday it would discontinue a trial testing its drug for the treatment of chronic cluster headache, after an analysis showed that the drug was unlikely to meet the study's main goal. The drug, fremanezumab, is under review by the U.S. Food and Drug Administration for prevention of migraines in adults and the...
The Food and Drug Administration on Thursday approved a generic version of Suboxone, a film strip that dissolves under the tongue. The generic version will be sold by partners Mylan N.V. and Dr. The FDA said the approval was aimed at making the treatment available to more people.
Mylan said U.S. health regulators were unable to approve its generic version of GlaxoSmithKline's blockbuster inhaled lung drug Advair for the second time.
Mylan did not provide details on the nature of the deficiencies cited by the U.S. Food And Drug Administration and it remains unclear whether the company will be able to resolve them and get approval this year. The FDA has declined to approve several Advair knock-offs in the past from drugmakers including Novartis AG, Hikma Pharmaceuticals and Mylan itself,...
Mylan did not provide details on the nature of the deficiencies cited by the FDA and it remains unclear whether the company will be able to resolve them and snag an approval this year. The U.S. Food And Drug Administration has declined several Advair knock-offs in the past from drugmakers including Novartis AG, Hikma Pharmaceuticals and Mylan itself, whose...
June 13- U.S. drugmaker Mylan NV said on Wednesday that U.S. health regulators could not approve its generic version of GlaxoSmithKline's blockbuster inhaled lung drug, Advair, and cited "minor deficiencies" with the copycat version. item= 123580 it expects to receive a formal complete response letter from the U.S. Food And Drug Administration on June 27 and would...
Kroger withdrew pre-cut cantaloupe, watermelon and melon mixes from its stores in Indiana and Michigan after the products were linked to possible contamination from a strain of Salmonella Adelaide, the Cincinnati Business Courier reports.
June 5- The U.S. Food and Drug Administration on Tuesday sent warning letters to nine online networks operating a total of 53 websites to stop illegally marketing unapproved versions of opioid medications. These steps by the regulator come at a time when the United States continues to grapple with an escalating opioid crisis. Opioids were involved in more than...
June 5- Abbvie Inc said on Tuesday its experimental drug met the main goal of halting progression of moderate-to-severe rheumatoid arthritis in a late-stage trial. The drug, upadacitinib, was tested as a monotherapy in patients who have not been treated with chemotherapy agent methotrexate. Last week, the Food and Drug Administration approved lower doses of...
June 4- The U.S. Food And Drug Administration on Monday approved a drug from Mylan NV as the first biosimilar to Amgen's drug Neulasta to help reduce the risk of infection during cancer treatment.
The balloon systems associated with the reports are made by ReShape Lifesciences and Apollo Endosurgery, the FDA said https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm609597. h t m. The FDA said that it was working with the device manufacturers to better understand the issues, and had approved labeling changes last week to...
June 4- The U.S. Food and Drug Administration on Monday notified healthcare providers that it had received reports of five more deaths in patients using liquid-filled intragastric balloon systems to treat obesity.
