Tag archive for ‘Drug Administration’
By news On Thursday, September 14th, 2017

Pfizer, Astellas prostate cancer drug succeeds key trial

(Reuters) – Pfizer Inc and Japan’s Astellas Pharma Inc said on Thursday their prostate cancer drug met the main goal of a trial testing it for a more common form of the disease. (adsbygoogle More...

By news On Wednesday, September 13th, 2017

Amicus to abandon wound treatment after late-stage failure

(Reuters) – U.S. drug developer Amicus Therapeutics Inc said on Wednesday it would no longer invest in clinical trials of its drug for healing wounds after the experimental treatment failed a late-stage More...

By news On Monday, September 11th, 2017

AbbVie reports two patient deaths in rheumatoid arthritis study

(Reuters) – AbbVie Inc said on Monday two patients died in a late-stage trial testing its rheumatoid arthritis drug, raising safety concerns about the drug. The drugmaker said the reason for one of the More...

By news On Friday, September 8th, 2017

U.S. FDA warns of problems with EpiPen manufacturing plant

(Reuters) – A U.S. regulator this week told Pfizer Inc’s Meridian Medical Technologies division, maker of the EpiPen injector device, that serious component and product failures have been associated with More...

By news On Wednesday, August 30th, 2017

Otonomy’s ear disease drug fails key trial, shares nosedive

(Reuters) – U.S. drugmaker Otonomy Inc said on Wednesday it would stop developing its drug to treat Meniere’s disease, a chronic, progressive disorder of the inner ear, after it failed a late-stage More...

By news On Tuesday, August 8th, 2017

FDA to launch campaign against e-cigarette use among youth

(Reuters) – Hot on the heels of its proposal to lower nicotine levels in cigarettes, the U.S. Food and Drug Administration on Tuesday announced plans for an education campaign to discourage use of electronic More...

By news On Saturday, August 5th, 2017

DEA proposes cutting production of some opioid painkillers

(Reuters) – The U.S. Drug Enforcement Administration (DEA) on Friday proposed a 20 percent reduction in the manufacture of certain commonly prescribed opioid painkillers as well as other controlled substances More...

By news On Thursday, August 3rd, 2017

Senate reauthorizes FDA to collect fees from drugmakers

(Reuters) – The U.S. Senate on Thursday passed a bill allowing the Food and Drug Administration to continue collecting fees from drug companies to review new product applications. The FDA Reauthorization More...

By news On Monday, July 31st, 2017

AstraZeneca drug gets breakthrough status in early lung cancer

LONDON (Reuters) – AstraZeneca said on Monday its immunotherapy drug Imfinzi had been granted “breakthrough” designation by U.S. regulators for treating non-metastatic lung cancer, following More...

By news On Saturday, July 29th, 2017

AbbVie’s drug for all types of hepatitis C wins EU approval

(Reuters) – AbbVie Inc said on Friday it had received European approval to market its drug for treatment of all six major forms of hepatitis C. The company said the approval of Maviret was supported by More...