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December 26, 2018 9:13 PM Sanofi's pediatric hexavalent vaccine approved by U.S. FDA

PARIS (Reuters) - The U.S. Food and Drug Administration approved Sanofi’s new pediatric vaccine immunizing children against six diseases, the French pharmaceutical lab said on Wednesday. Sanofi developed the new vaccine, dubbed Vaxelis, in partnership with Merck. Vaxelis is designed for children aged 6 weeks to 4 years old and is designed to keep them from contracting 90

December 21, 2018 5:21 PM Alexion wins early U.S. approval for rare blood disorder drug

(Reuters) - The U.S. Food and Drug Administration approved on Friday Alexion Pharmaceuticals Inc’s rare blood disorder drug Ultomiris, an early backing that also solidifies the company’s dominant market position. The company’s flagship drug, Soliris, was the lone FDA-approved treatment for the blood disorder, paroxysmal nocturnal hemoglobinuria (PNH) 111

December 20, 2018 7:26 PM U.S. FDA approves new protocol for study on Bayer's birth control device

(Reuters) - The U.S. Food and Drug Administration on Thursday approved a new protocol for a post-marketing study of Bayer AG’s Essure birth-control device, as the regulator seeks more information on the device’s safety. The study would now monitor here women implanted with the devices for five years, up from three years, and would need additional blood 90

December 19, 2018 8:49 PM U.S. agency recommends opioid overdose antidote to high-risk patients

(Reuters) - The U.S. Department of Health and Human Services (HHS) on Wednesday recommended prescribing or co-prescribing the opioid overdose reversal drug, naloxone, to high-risk patients. The agency’s recommendation comes a day after an advisory panel to the U.S. Food and Drug Administration (FDA) narrowly recommended prescribing the drug, along with addictive 102

December 5, 2018 2:32 PM U.S. FDA removes safety warning from Smith & Nephew's diabetic gel

(Reuters) - British medical products maker Smith & Nephew said on Wednesday that the U.S. Food and Drug Administration (FDA) had approved the removal of a safety warning on its treatment for lower extremity diabetic neuropathic ulcers. The label on the box of the Regranex gel since 2008 warned of “increased rate of mortality secondary to malignancy 101

December 3, 2018 6:41 AM Novartis SMA treatment could get FDA approval in May

ZURICH (Reuters) - Novartis’s gene therapy for spinal muscular atrophy (SMA) could be approved in May 2019 after the U.S. Food and Drug Administration agreed to an accelerated review of the Swiss drugmaker’s treatment. Novartis SMA treatment, now called Zolgensma, said on Monday it won FDA priority review after submitting clinical trial results for 15 patients 101

November 29, 2018 12:49 AM FDA approves first biosimilar to Roche cancer drug Rituxan

(Reuters) - Celltrion Inc’s Truxima on Wednesday became the first biosimilar to Roche Holding AG’s $7-billion-per-year cancer drug Rituxan to be approved in the United States to treat non-Hodgkin’s lymphoma. The approval by the U.S. Food and Drug Administration is part of the agency’s plan to encourage development of cheaper biosimilars amid rising prices 115

November 28, 2018 8:31 PM Astellas Pharma gets U.S. nod for blood cancer treatment

(Reuters) - The U.S. Food and Drug Administration on Wednesday approved a blood cancer treatment from Japan’s Astellas Pharma Inc, making it the first targeted therapy to treat patients with a certain mutation. The treatment, Xospata, was approved for patients with acute myeloid leukemia (AML) with a FLT3 mutation, whose cancer has relapsed or proved 107

November 27, 2018 6:34 PM FDA finds traces of heavy metals in kratom products

The FDA has been clamping down on the substance, which advocates say help ease pain and reduce symptoms of opioid withdrawal, but which the agency says has similar effects to narcotics such as opioids and has resulted in dozens of deaths. (AP) The U.S. Food and Drug Administration said on Tuesday it had found high levels of heavy metals such as lead and nickel 105

November 16, 2018 11:11 PM Novartis' blood disorder drug gets FDA approval for expanded use

(Reuters) - Novartis AG said on Friday the U.S. Food and Drug Administration expanded the use of its low platelets drug to treat patients with a rare, genetic blood disorder. The drug, Promacta, received the green light as a combination with standard immunosuppressive therapy to treat patients two years and older suffering from treatment-resistant severe 120