FDA Approves Pediatric Indication for Xeomin (incobotulinumtoxina) for the Treatment of Chronic Sialorrhea

RALEIGH, N.C., December 21, 2020 — Merz Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Xeomin (incobotulinumtoxinA) for the treatment of patients aged 2 years and older with chronic sialorrhea, or drooling. Xeomin is the first and only FDA-approved neuromodulator with this indication and was granted a priority review […]

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Trump congratulates the FDA as it green lights Moderna's COVID vaccine

Trump congratulates the FDA as it green lights Moderna’s COVID-19 vaccine: US authorizes second shot in seven days and readies to ship nearly 6 million doses by Christmas Trump tweeted: ‘Congratulations, the Moderna vaccine is now available!’  Regulators gave emergency approval to Moderna’s 94% effective COVID-19 vaccine on Friday evening FDA Commissioner Stephen Hahn called the availability of two vaccines […]

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FDA Approves Oxlumo

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1 CAMBRIDGE, Mass.–(BUSINESS WIRE)–Nov. 24, 2020– Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate […]

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Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine

In addition to today’s submission to the FDA, the companies have already initiated rolling submissions across the globe including in Australia, Canada, Europe, Japan and the U.K., and plan to submit applications immediately to other regulatory agencies around the world Based on current projections, the companies expect to produce globally up to 50 million doses in 2020 and up to […]

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FDA panel reviews 1st new Alzheimer’s drug in 2 decades

One of the biggest drug decisions in decades is looming as U.S. regulators consider whether to approve the first medicine that’s claimed to slow mental decline from Alzheimer’s disease, the most common form of dementia. A panel of outside experts meets Friday to advise the Food and Drug Administration on aducanumab, a drug from Cambridge, Massachusetts-based Biogen Inc. and Japan’s […]

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FDA Grants Fast Track Designation for ASP0367/MA-0211, a Selective PPARδ Modulator being Developed for the Treatment of Primary Mitochondrial Myopathies

TOKYO, Oct. 20, 2020 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of ASP0367/MA-0211 (“ASP0367”) as a potential treatment for primary mitochondrial myopathies (PMM). PMM is a complex mitochondrial disease in which genetic mutations primarily impair the function of […]

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FDA list of fraudulent coronavirus products grows

Fox News Flash top headlines for October 12 Fox News Flash top headlines are here. Check out what’s clicking on Foxnews.com. The U.S. Food and Drug Administration’s list of firms selling fraudulent products claiming COVID-19 cures, treatments or otherwise continues to grow. The list now amounts to 118 firms, 72% of which are listed in a “corrective status,” meaning the products […]

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Dangerous 'Benadryl challenge' prompts warning from FDA over high doses of medication

Fox News Flash top headlines for September 25 Fox News Flash top headlines are here. Check out what’s clicking on Foxnews.com. The U.S. Food and Drug Administration (FDA) on Thursday released a warning over serious health issues, and even death, tied to higher than recommended doses of over-the-counter antihistamine drug diphenhydramine (Benadryl). The warning was prompted by a dangerous fad […]

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If prescribed opioids for pain, ask lots of questions: FDA

(HealthDay)—If your doctor prescribes opioid painkillers such as hydrocodone, oxycodone, codeine or morphine for you, there are a number of questions you should ask, the U.S. Food and Drug Administration advises. Opioids can be used to treat certain kinds of acute and chronic pain, but can have some serious side effects, most notably addiction. If you’re prescribed opioids, the FDA […]

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FDA may approve emergency use of Ebola drug remdesivir TODAY

BREAKING NEWS: FDA may approve emergency use authorization of Ebola drug remdesivir TODAY after Dr Fauci called early results of one study ‘very optimistic’ The FDA may announce its decision allowing emergency use authorization of an antiviral remdesivir for coronavirus patients as early as Wednesday It comes as Gilead Sciences treated 397 severely ill patients and found  more than half of […]

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