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Monday, May 27, 2019

11:18:00 AM CEST

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Richard Pazdur said: "Piqray is the first PI3K inhibitor to demonstrate a clinically meaningful benefit in treating patients with this type of breast cancer. The ability to target treatment to a patient's specific genetic mutation or biomarker is becoming increasingly common in cancer treatment, and companion diagnostic tests assist oncologists in selecting patients who may benefit from these targeted treatments," External link

prnewswire Friday, May 24, 2019 9:00:00 PM CEST

Peter Marks said: "Children with SMA experience difficulty performing essential functions of life. Most children with this disease do not survive past early childhood due to respiratory failure" External link

finanzen-ch Friday, May 24, 2019 6:42:00 PM CEST

Mark Edwards stated: “We’re off to a solid start this fiscal year with record-breaking year-over-year revenue growth as well as a number of exciting announcements,” External link

globenewswire Wednesday, May 22, 2019 10:22:00 PM CEST

Mark Edwards concluded: “I am confident in the steps we are taking to create sustainable growth and look forward to continuing to build momentum throughout 2019,” External link

globenewswire Wednesday, May 22, 2019 10:22:00 PM CEST

Jeff Shuren said: "Millions of Americans use continuous glucose monitors and insulin delivery devices to monitor and treat their diabetes. Because of the complexity of these devices and the life-saving care they provide, it's important that patients are aware of the risks that arise when they're not used as intended or when they use devices not authorized for sale in the U.S. By using products that have not been reviewed by the agency for safety and effectiveness, patients with diabetes may be putting themselves at risk for serious injury or even death," External link

prnewswire Friday, May 17, 2019 6:14:00 PM 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 Thursday, May 16, 2019 6:31:00 PM CEST

Jeffrey Shuren said: “In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” External link

fda Thursday, May 16, 2019 3:19:00 AM CEST

Billy Dunn said: “We continue to be committed to facilitating the development and approval of treatments for rare diseases, particularly those in children,” External link

fda Thursday, May 16, 2019 3:19:00 AM CEST

Richard Pazdur said: “Prior to today’s approval, there had been no FDA approved therapies for BPDCN. The standard of care has been intensive chemotherapy followed by bone marrow transplantation. Many patients with BPDCN are unable to tolerate this intensive therapy, so there is an urgent need for alternative treatment options,” External link

fda Wednesday, May 8, 2019 6:04:00 PM CEST

Janet Woodcock said: “The agency expedited the review and approval of this application because Benlysta IV fulfils an unmet need for therapies, specifically in pediatric patients with SLE. While there is no cure for lupus, treatment can help our youngest patients control their disease with the hope of improving their quality of life and lowering their risk of long-term organ damage and disability,” External link

fda Wednesday, May 8, 2019 6:04:00 PM 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, May 8, 2019 6:04:00 PM CEST

Billy Dunn said: "We continue to be committed to facilitating the development and approval of treatments for rare diseases, particularly those in children," External link

finanzen-ch Monday, May 6, 2019 11:55:00 PM CEST

Jorge Casado said: “There is huge uncertainty about what effects these mixtures of chemicals could have on wildlife and human health,” External link

treehugger Saturday, May 4, 2019 4:47:00 PM CEST

Paul Johnston said: “This is not a case of us versus farmers or water companies,” External link

treehugger Saturday, May 4, 2019 4:47:00 PM 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

markets-businessinsider Tuesday, April 30, 2019 7:31:00 PM CEST

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