Food and Drug Administration

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The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
Food and Drug Administration
Definition
The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.

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Food and Drug Administration

Food and Drug Administration
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The Food and Drug Administration approved Ubrelvy, the company’s ubrogepant treatment, on Monday. The oral medication is aimed at treating migraines in patients who are unresponsive to common migraine treatments, such as triptans, or are at risk of cardiovascular disorders. Allergan, which anticipated a December approval by the FDA, said Ubrelvy will be available for sale in the U.S. in the first quarter.

The U.S. Food and Drug Administration today approved Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. Ubrelvy is not indicated for the preventive treatment of migraine. It is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists approved for the acute treatment of migraine.

The US Food and Drug Administration on Monday announced the approval of a drug called ubrogepant for the acute treatment of migraine, which could be a new option for people who can't take or don't respond to migraine medications currently on the market.

The U.S. Food and Drug Administration has approved a new drug to treat migraines.

Discovered and developed by AbbVie, RINVOQ is a selective and reversible JAK inhibitor studied in several immune-mediated inflammatory diseases. In August 2019, RINVOQ received U.S. Food and Drug Administration approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. In December 2019, RINVOQ also received approval by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. Phase 3 trials of RINVOQ in rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, atopic dermatitis, ulcerative colitis and giant cell arteritis are ongoing.

What was once a debilitating condition may now be easily and quickly treatable thanks to a recent FDA announcement on the approval of a new migraine treatment. The medication, Ubrelvy, was found to work in as little as two hours to offer relief to migraine patients.

For those who suffer from insomnia, the answer is not simple. Of the few medications on the market, many cause a slew of unpleasant and sometimes dangerous side effects. However, recently the FDA approved a new insomnia medication that may serve as an alternative. The drug, named lemborexant (Dayvigo), was found to particularly help seniors stay asleep.

Japan-based drugmaker Eisai Co’s U.S. subsidiary announced on Sunday that it had received approval from the U.S. Food and Drug Administration for its insomnia treatment in adult patients.

Intra-Cellular Therapies Inc said on Monday its lead drug to treat schizophrenia in adults has received approval from the U.S. Food and Drug Administration, sending its shares soaring 85%.

The federal Food and Drug Administration has approved a gene therapy for a rare childhood disorder that is now the most expensive drug on the market. It costs $2.125 million per patient.

AbbVie Inc said on Tuesday that the U.S. Food and Drug Administration approved its Skyrizi drug as a treatment for plaque psoriasis at a time when its blockbuster psoriasis drug, Humira, faces patent pressures.

Seqirus announced FDA approval of Audenz, the first-ever adjuvanted and cell-based vaccine against influenza A (H5N1) in the event of a pandemic.

“Even with strict avoidance, inadvertent exposures can and do occur. When used in conjunction with peanut avoidance, Palforzia provides an FDA-approved treatment option to help reduce the risk of these allergic reactions,” said Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research.

One of Eli Lilly's drugs, Trijardy XR, was approved by the FDA this week, and top-line results were announced from a Phase 3 clinical trial for another. Trijardy XR combines three type 2 diabetes medications into one pill that, combined with diet and exercise, lowers blood-sugar levels in adults. This combination of different diabetes medications marks an important advancement in the treatment of the disease.

Epizyme, Inc. (Nasdaq: EPZM), a biopharmaceutical company developing novel epigenetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of TAZVERIK™ (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection, based on overall response rate and duration of response in a Phase 2 clinical trial.

The FDA approved ferric derisomaltose injection for the treatment of iron deficiency anemia in adults who had an intolerance or unsatisfactory response to oral iron or who have nonhemodialysis-dependent chronic kidney disease, according to a press release from the drug’s manufacturer.

While using cocaine recreationally remains illegal, the drug does have some use in the medical profession. As it turns out, the Food and Drug Administration (FDA) has approved a nasal spray that contains cocaine as one of its ingredients.

At month end, the company’s PUR1900 ("Pulmazole") received the fast track designation from the FDA. The proprietary product is an inhaled itraconazole antifungal candidate being developed to treat allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma.

Illumina has appointed Scott Gottlieb to its board of directors. Gottlieb is currently a special partner at New Enterprises Associates and a resident fellow at the American Enterprise Institute. He previously served as the 23rd commissioner of the US Food and Drug Administration form 2017 to 2019. Prior to joining the US FDA as commissioner, Gottlieb was a clinical assistant professor at the New York University School of Medicine.

The US Food and Drug Administration has awarded a five-year, $20 million contract to the team of DNAnexus and Deloitte to run the collaborative omics environment for the PrecisionFDA cloud-based next-generation sequencing platform.

And the costs of the inefficient, error-prone process that is drug discovery are not only high but increasing. Where Moore’s Law illustrates the cheapening and "easy access" of digitization in many technology fields, the pharmaceutical industry has the cleverly named Eroom’s Law ("Moore" spelled backward), described by Jack Scannell and team in 2012, that shows that the number of new drugs approved by the FDA per billion U.S. dollars (inflation-adjusted) spent on R&D has halved roughly every 9 years.

They’re also moving into the public health and food safety sector, as agencies like the Food and Drug Administration perform half a billion food pathogen tests every year, which are now being converted to being genomics based tests.

This is not to say that no startups are working to commercialize this technology. Last year, CureMetrix became the first company to receive FDA approval for its AI-based breast cancer technology; the company plans to deploy in several clinical settings this year. Other startups angling to commercialize and scale AI-based radiology in the near term include Arterys, Aidoc, Zebra Technologies and DeepHealth.

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