Food and Drug Administration

The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
Latest trending news and information about the Food and Drug Administration.
  • Water Pik recalls flossing product over overheating risk
    Local 10 Miami

    Water Pik recalls flossing product over overheating risk

    MIAMI - Water Pik recalled its Sonic-Fusion flossing toothbrush over overheating of the charging base warning that it could cause a fire, shock or burns, according to federal authorities.  The Food & Drug Administration announced the recall of some 3,800 units applied to both the SF-01 and the SF-02 models. The serial numbers are 06 01 through 18 06 28 and were sold from June 2017 to June 2018 in the U.S. and Canada.   Officials advise anyone who owns these units to stop using them immediately. Unplug the unit and return it to Water Pik. For more information, call from 7 a.m. to 5 p.m. at 1-800-674-7718 or e-mail SonicFusion-Return@Waterpik.com.

  • GlobeNewswire

    Nohla Therapeutics Receives FDA Orphan Drug Designation for Dilanubicel for Hematopoietic Stem Cell Transplant Patients

    SEATTLE, July 16, 2018-- Nohla Therapeutics, a leading developer of universal, off-the-shelf cell therapies for patients with hematologic malignancies and other critical diseases, today announced that ...

  • 247wallst.com

    Why Tonix Pharmaceuticals Is Winning Big on Monday

    Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) saw its shares make a solid gain to start off the week after the company announced an update from the U.S. Food and Drug Administration (FDA) regarding its Alzheimer's agitation treatment. Specifically, the FDA granted Fast Track designation to Tonix's investigational new drug, TNX-102 SL, for the treatment of agitation in Alzheimer's disease. The same drug, TNX-102 SL, or Tonmya, for the treatment of post-traumatic stress disorder (PTSD), has previously been designated as a Breakthrough Therapy by the FDA.  It is currently in a Phase 3 study for military-related PTSD, with an interim analysis expected in the third quarter of 2018. Previously,

  • J&J's (JNJ) Invokana Label Expansion Filing Hit by FDA Delay
    Zacks

    J&J's (JNJ) Invokana Label Expansion Filing Hit by FDA Delay

    The FDA defers decision regarding label expansion application to include cardiovascular indication on the label of J&J's (JNJ) diabetes drug Invokana.

  • Crab meat linked to a outbreak of a diarrhea-causing illness, FDA says
    Miami Herald

    Crab meat linked to a outbreak of a diarrhea-causing illness, FDA says

    Fresh crab meat from Venezuela commonly served in restaurants and sold in supermarkets has been linked to a multi-state outbreak of Vibrio parahaemolyticus, by the U.S. Food and Drug Administration and Centers for Disease Control. Four people have been hospitalized in the outbreak, the CDC said. “Consumers are advised to ask where their crab meat is from, if dining out at a restaurant or in grocery stores,” the FDA said in a late Friday outbreak alert. “This product is commonly found in plastic tubs and may be labeled as “pre-cooked.” “Retailers should not serve or sell fresh crab meat imported from Venezuela.” The CDC warns, “Food contaminated with Vibrio parahaemolyticus usually looks, smells,

  • Business Standard

    Alembic Pharma gets tentative USFDA nod for Ticagrelor tablets

    Drug firm Alembic Pharmaceuticals has received tentative approval from the US health regulator for Ticagrelor tablets, used to reduce the rate of cardiovascular death and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction (MI). "The company has got tentative approval from the US Food and Drug Administration (USFDA) to market the drug in the strength of 90 mg," Alembic Pharmaceuticals said in a BSE filing. The tentatively approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to the reference listed drug product (RLD), Brilinta tablets of Astrazeneca Pharmaceuticals LP. Quoting IQVIA sales data, the company said, Ticagrelor tablets,

  • FDA OKs 1st drug to treat smallpox, in case of terror attack
    Plainview Daily Herald

    FDA OKs 1st drug to treat smallpox, in case of terror attack

    Caption Close U.S. regulators Friday approved the first treatment for smallpox — a deadly disease that was wiped out four decades ago — in case the virus is used in a terror attack. Smallpox, which is highly contagious, was eradicated worldwide by 1980 after a huge vaccination campaign. But people born since then haven't been vaccinated, and small samples of the smallpox virus were saved for research purposes, leaving the possibility it could be used as a biological weapon. Maker SIGA Technologies of New York has already delivered 2 million treatments that will be stockpiled by the government, which partially paid for the development of the drug, called TPOXX. To test the drug's effectiveness,

  • markets.businessinsider.com

    Gala Therapeutics Receives FDA IDE Approval for a US Early Feasibility Study of Its RheOx™ System to Treat Chronic Bronchitis

    MENLO PARK, Calif., July 12, 2018 /PRNewswire/ -- Gala Therapeutics (Gala) today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to conduct an Early Feasibility Study (EFS) to examine the safety of the RheOx™ system in subjects with Chronic Bronchitis.  The study will enroll up to 15 patients at 5 clinical trial sites in the United States. "Patients with Chronic Bronchitis suffer daily with mucus hypersecretion and cough," stated Jonathan Waldstreicher, MD, Chief Executive Officer of Gala.  "We developed the Bronchial Rheoplasty™ procedure to directly treat the abnormal airway cells responsible for Chronic Bronchitis, which

  • Wary of terror attack, U.S. approves first drug to treat smallpox
    Los Angeles Times

    Wary of terror attack, U.S. approves first drug to treat smallpox

    Smallpox killed about 300 million people worldwide in the 20th century before its eradication. Symptoms include fever, fatigue and pus-filled sores. Until now, doctors could only provide supportive care such as IV fluids and fever remedies and isolate the patients. Vaccination can be used to prevent infection, but it must be done within five days of exposure to the virus, well before symptoms appear.

  • FDA Fast Facts: FDA works with partners to investigate a Cyclospora outbreak potentially associated with McDonald's salads
    PR Newswire

    FDA Fast Facts: FDA works with partners to investigate a Cyclospora outbreak potentially associated with McDonald's salads

    SILVER SPRING, Md., July 13, 2018 /PRNewswire/ -- The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention, along with state and local officials, are investigating a multi-state outbreak of Cyclospora infections. Yesterday, the Illinois and Iowa Health Departments identified McDonald's salads as being potentially linked to cases of Cyclospora in both states. McDonald's has voluntarily stopped selling salads at affected restaurants across 14 states and the CDC reports that 61 people across seven states have gotten sick.