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Tuesday, March 31, 2020

9:22:00 PM CEST

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Richard Pazdur said: “Oxbryta is an inhibitor of deoxygenated sickle hemoglobin polymerization, which is the central abnormality in sickle cell disease,” External link

fda Wednesday, March 25, 2020 6:09:00 AM CET

Peter Marks said: “Peanut allergy affects approximately 1 million children in the U.S. and only 1 out of 5 of these children will outgrow their allergy. Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions,” External link

fda Wednesday, March 25, 2020 6:09:00 AM CET

Anna Abram said: “While the risk of Ebola virus disease in the U.S. remains low, the U.S. government remains deeply committed to fighting devastating Ebola outbreaks in Africa, including the current outbreak in the Democratic Republic of the Congo,” External link

fda Wednesday, March 25, 2020 6:09:00 AM CET

Peter Marks said: “Ebola virus disease is a rare but severe and often deadly disease that knows no borders. Vaccination is essential to help prevent outbreaks and to stop the Ebola virus from spreading when outbreaks do occur,” External link

fda Wednesday, March 25, 2020 6:09:00 AM CET

Billy Dunn said: “Migraine is an often disabling condition that affects an estimated 37 million people in the U.S.,” External link

fda Wednesday, March 25, 2020 6:09:00 AM CET

Peter Marks said: “As the regulators of these novel therapies, we know that the framework we construct for product development and review will set the stage for continued advancement of this cutting-edge field and further enable innovators to safely develop effective therapies for many diseases with unmet medical needs,” External link

fda Wednesday, March 25, 2020 6:09:00 AM CET

Janet Woodcock said: “We are continuing our investigation along with our international counterparts, and we will keep the American public informed of any additional recalls as well as the potential risks from taking ranitidine products,” External link

fda Wednesday, March 25, 2020 5:47:00 AM CET

Peter Marks said: “In the case against US Stem Cell Clinic, the clinic and its leadership have put patients at serious risk through their disregard of the law and prior FDA warnings. This decision today is a victory for the FDA’s work to stop these bad actors and to protect patients,” External link

fda Wednesday, March 25, 2020 5:47:00 AM CET

Lisa Yanoff said: “Patients want effective treatment options for diabetes that are as minimally intrusive on their lives as possible, and the FDA welcomes the advancement of new therapeutic options that can make it easier for patients to control their condition,” External link

fda Wednesday, March 25, 2020 5:47:00 AM CET

Richard Pazdur said: “In addition to the international collaboration with Australia and Canada, this review used the ‘Real-Time Oncology Review’ (RTOR) pilot program, which can streamline the submission of data prior to the completion and submission of the entire clinical application,” External link

fda Wednesday, March 25, 2020 5:47:00 AM CET

Janet Woodcock said: “Today’s approval of the first generics for pregabalin, a widely-used medication, is another example of the FDA’s longstanding commitment to advance patient access to lower cost, high-quality generic medicines,” External link

fda Wednesday, March 25, 2020 5:47:00 AM CET

Ed Cox said: “This new drug provides another option for the treatment of patients with community-acquired bacterial pneumonia, a serious disease,” External link

fda Wednesday, March 25, 2020 5:47:00 AM CET

Richard Pazdur said: “While there is no cure for multiple myeloma, there are FDA-approved treatments to target the cancer and slow down the spread of the disease. Sadly, often over time, patients can exhaust all available treatments and still see their disease progress,” External link

fda Wednesday, March 25, 2020 5:47:00 AM CET

Eric Bastings said: "Parkinson’s disease is a debilitating condition that profoundly impacts patients' lives," External link

fda Wednesday, March 25, 2020 5:47:00 AM CET

Ed Cox said: “The FDA remains focused on facilitating the development of safe and effective new antibacterial drugs to give patients more options to fight serious infections,” External link

fda Wednesday, March 25, 2020 5:47:00 AM CET

Janet Woodcock said: “People who are living with diabetes are at risk of their blood sugar levels falling below the normal range. There are many products on the market for those who need insulin, but until now, people suffering from a severe hypoglycemic episode had to be treated with a glucagon injection that first had to be mixed in a several-step process,” External link

fda Wednesday, March 25, 2020 5:47:00 AM CET

Nikola Nikolov said: “The Rituxan application for pediatric GPA and MPA was approved under a priority review, and with orphan designation, to fulfil an unmet medical need for these rare and serious diseases. Rituxan provides a treatment option that has not existed until now for children who suffer from these diseases,” External link

fda Wednesday, March 25, 2020 5:47:00 AM CET

Peter Marks said: “We encourage firms to engage with the FDA about regulatory oversight of this field and work with the agency for appropriate development, including designing clinical trials, to explore the safety and potential benefits of these products. We intend to step up our oversight of those sponsors who have not engaged the regulatory process in the proper development of their stem cell products that are regulated as drugs, devices, and/or biological products under the statutes and existing regulations, and whose products create more significant potential risks because of the way that they’re manipulated or delivered,” External link

fda Wednesday, March 25, 2020 5:47:00 AM CET

Richard Pazdur said: “TGCT can cause debilitating symptoms for patients such as pain, stiffness and limitation of movement. The tumor can significantly affect a patient’s quality of life and cause severe disability,” External link

fda Wednesday, March 25, 2020 5:47:00 AM CET

Janet Woodcock said: “We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” External link

fda Wednesday, March 25, 2020 5:14:00 AM CET

Scott Gottlieb added: “We have an obligation to provide caregivers and patients with the confidence that drugs making cancer treatment claims have been carefully evaluated for safety, efficacy, and quality, and are monitored by the FDA once they’re on the market,” “We recognize that there’s interest in developing therapies from marijuana and its components, but the safest way for this to occur is through the drug approval process – not through unsubstantiated claims made on a website. We support sound, scientifically-based research using components derived from marijuana, and we’ll continue to work with product developers who are interested in bringing safe, effective, and quality products to market” External link

fda Wednesday, March 25, 2020 4:36:00 AM CET

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