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Saturday, September 21, 2019

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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 Friday, September 20, 2019 4:39:00 PM CEST

David Gordon told: “Whether it’s (at) the industrial-level livestock or family pets, it’s an area that’s taken seriously. And as we explore it, it hasn’t been a primary focus for anybody at this stage,” External link

investingnews Wednesday, September 18, 2019 2:34:00 AM CEST

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 Tuesday, September 17, 2019 5:48:00 PM CEST

Richard Pazdur said: “Today’s approval includes an indication for pediatric patients, 12 years of age and older, who have NTRK-fusion-positive tumors by relying on efficacy information obtained primarily in adults. The FDA continues to encourage the inclusion of adolescents in clinical trials. Traditionally, clinical development of new cancer drugs in pediatric populations is not started until development is well underway in adults, and often not until after approval of an adult indication,” External link

fda Wednesday, September 11, 2019 9:15:00 AM CEST

Richard Pazdur said: “Prior to today, there was one FDA-approved drug to treat patients with myelofibrosis, a rare bone marrow disorder. Our approval today provides another option for patients,” External link

fda Wednesday, September 11, 2019 9:15:00 AM CEST

Nikola Nikolov said: “Patients suffering from scleroderma need effective therapies, and the FDA supports the efforts of drug companies that are designing and conducting the clinical trials necessary to bring treatment options to scleroderma patients,” External link

fda Wednesday, September 11, 2019 9:15:00 AM CEST

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, September 11, 2019 7:44:00 AM CEST

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

fda Wednesday, September 11, 2019 7:44:00 AM CEST

Janet Woodcock said: “We have closely watched the safety profile of these drugs since they were approved. When our ongoing safety monitoring recently reflected the risk of more serious injuries and deaths from patients on these medications who experienced complex sleep behaviors, we determined there was a need to take stronger steps to inform the public,” External link

fda Wednesday, September 11, 2019 7:14:00 AM CEST

Douglas Throckmorton said: “In the wake of the opioid crisis, a number of efforts are underway to make this emergency overdose reversal treatment more readily available and more accessible. In addition to this approval of the first generic naloxone nasal spray, moving forward we will prioritize our review of generic drug applications for naloxone. The FDA has also taken the unprecedented step of helping to assist manufacturers to pursue approval of an over-the-counter naloxone product and is exploring other ways to increase the availability of naloxone products intended for use in the community, including whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death,” External link

fda Wednesday, September 11, 2019 7:14:00 AM CEST

Benjamin Fisher said: “Sadly, too many patients on transplant lists die waiting for suitable lungs. Providing patients with access to safe medical devices that have the potential to be lifesaving remains a top FDA priority, and we support the development of innovative technologies that can increase the donor organ pool for transplant patients in need of suitable lungs,” External link

fda Wednesday, September 11, 2019 7:14:00 AM CEST

Richard Pazdur said: “Most children who have VTE are fighting a serious underlying primary illness such as cancer or congenital heart disease. Not only are they fighting a serious illness, having a condition like VTE can then lead to significant complications and even death,” External link

fda Wednesday, September 11, 2019 7:14:00 AM CEST

Richard Pazdur said: "Primary HLH is a rare and life-threatening condition typically affecting children and this approval fills an unmet medical need for these patients," External link

fda Wednesday, September 11, 2019 6:44:00 AM CEST

Nikola Nikolov said: “Today’s approval of Cimzia fulfills an unmet need for patients suffering from non-radiographic axial spondyloarthritis as there has been no FDA-approved treatments until now,” External link

fda Wednesday, September 11, 2019 6:44:00 AM CEST

Edward Cox said: "Travelers' diarrhea affects millions of people each year and having treatment options for this condition can help reduce symptoms of the condition," External link

fda Wednesday, September 11, 2019 6:44:00 AM CEST

Tiffany Farchione said: "Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond. This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option," External link

fda Wednesday, September 11, 2019 6:44:00 AM CEST

Rachel Sherman said: “The clinical trials grant program is an important part of the FDA’s ongoing commitment to encouraging and supporting the development of safe and effective therapies for rare diseases,” External link

foreignaffairs-nz Wednesday, September 11, 2019 6:24:00 AM CEST

Edward Cox said: “The use of fluoroquinolones has a place in the treatment of serious bacterial infections — such as certain types of bacterial pneumonia — where the benefits of these drugs outweigh the risks, and they should remain available as a therapeutic option. The FDA remains committed to keeping the risk information about these products current and comprehensive to ensure that health care providers and patients consider the risks and benefits of fluoroquinolones and make an informed decision about their use,” External link

fda Wednesday, September 11, 2019 6:14:00 AM CEST

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, September 11, 2019 6:14:00 AM CEST

Steven Solomon said: “It’s critical that animal producers take the necessary steps to ensure that their food is safe for people to eat, and this includes following the instructions on a drug’s label when treating an animal to ensure that no harmful drug residues are left in the animal’s tissues,” External link

fda Wednesday, September 11, 2019 6:14:00 AM CEST

Sonny Perdue said: “Government should make things easier for our customers whenever possible and these important improvements help accomplish that goal,” “Specialty crop farmers who take advantage of a USDA Harmonized GAP audit now will have a much greater likelihood of passing a FSMA inspection as well. This means one stop at USDA helps producers meet federal regulatory requirements, deliver the safest food in the world and grow the market for American-grown food. This is an important first step. We look forward to continuing to work with FDA, other government agencies and especially our state partners to ensure proper training of auditors and inspectors, and to help producers understand changes in the audit” External link

fda Wednesday, September 11, 2019 6:14:00 AM CEST

Scott Gottlieb said: “We’re committed to working with USDA to pursue our shared goal of advancing food safety in a way that is efficient and helps farmers meet our regulatory standards. By working together, our two programs can advance these efforts more effectively,” “Today’s announcement will help FDA and states better prioritize our inspectional activities by using USDA H-GAP audit information to prioritize inspectional resources and ultimately enhance our overall ability to protect public health. Inspections are key to helping to ensure that produce safety standards are being met, but they only provide a snapshot in time. Leveraging the data and work being done by USDA will provide us with more information so that we can develop a clearer understanding of the safety and vulnerabilities on produce farms as well as concentrate our oversight and resources where they are most needed” External link

fda Wednesday, September 11, 2019 6:14:00 AM CEST

Carlos Pena said: “Time is critical following the onset of stroke symptoms. Expanding the treatment window from 6 to 24 hours will significantly increase the number of stroke patients who may benefit from treatment,” External link

fda Wednesday, September 11, 2019 5:43:00 AM CEST

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